Federal Register: July 7, 1997 (Volume 62, Number 129)
Proposed Rules
Page 36243-36248
From the Federal Register Online via GPO Access wais.access.gpo.gov
DOCID:fr07jy97-20
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Chapter I
Docket No. 97N-0218
RIN 0910-ZA01
Consideration of Codex Alimentarius Standards
AGENCY: Food and Drug Administration, HHS.
ACTION: Advance notice of proposed rulemaking.
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SUMMARY: The Food and Drug Administration (FDA) is announcing that it
is considering the amendment of its regulations that establish
procedures for review and evaluation of standards adopted by the Codex
Alimentarius Commission (Codex). Codex is an international body that
establishes food standards under the joint auspices of the United
Nations World Health Organization (WHO) and Food and Agriculture
Organization (FAO). FDA is considering whether to establish procedures
for the systematic review of standards and related texts adopted by
Codex. This action has the potential to enhance consumer protection
with regard to foods, to promote international harmonization, to enable
FDA to better meet its public health mission, and to fulfill U.S.
obligations under international agreements. The agency is soliciting
comments from interested persons about whether to amend agency
regulations to provide procedures for consideration of Codex standards,
how to best set priorities and evaluate various Codex standards for
possible acceptance by FDA, and how evaluation of each such standard
could be accomplished in the most transparent, efficient, and resource-
effective manner. FDA also invites comments on the agency's preliminary
views on these matters.
DATES: Written comments by October 6, 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.
FOR FURTHER INFORMATION CONTACT: John W. Jones, Office of Constituent
Operations (HFS-550), Food and Drug Administration, 200 C St. SW.,
Washington, DC 20204, 202-205-4311.
SUPPLEMENTARY INFORMATION:
I. Background
A. FDA's Policy Regarding International Standards
Codex is an international food standard-setting organization
composed of national Governments that establishes ``standards''
comparable in scope and intent to certain standards established by FDA.
For the purpose of this notice, the term ``standard'' refers to any
numerical limit, such as a tolerance, maximum residue limit or maximum
use level; a commodity or food standard of identity or composition; a
code of practice; a procedure; a guideline; a labeling requirement; and
a method, general recommendation, or other related text that may be
adopted by Codex through its formal eight-step procedure (Ref. 1, Codex
Procedural Manual, Ninth ed., FAO/WHO Rome, 1995).
In a notice published in the Federal Register of October 11, 1995
(60 FR 53078), FDA articulated its policy regarding the development and
use of standards with respect to the harmonization of various national
and international regulatory requirements and guidelines. FDA's policy
addressed specifically the conditions under which FDA plans to
participate in international standard-setting organizations in the
development of standards applicable to products regulated by FDA and
defined the conditions under which the agency intends to use the
resultant standards in fulfilling its statutory mandate to safeguard
the public health.
The October 11, 1995, notice stated in part:
It is the intent of this policy to enable FDA to: (1) Continue
to participate in international standards activities that assist it
in implementing statutory provisions for safeguarding the public
health, (2) increase its efforts to harmonize its regulatory
requirements with those of foreign governments, including setting
new standards that better serve public health, and (3) respond to
laws and policies such as the Trade Agreements Act and OMB Circular
No. A-119 that encourage agencies to use international standards
that provide the desired degree of protection.
The policy statement concluded that the agency's primary goal in
participation in such standard-setting activities and use of resultant
standards is to preserve and enhance its ability to accomplish FDA's
public health mission, with the aim of enhancing regulatory
effectiveness, providing more consumer protection with increasingly
scarce government resources, and increasing worldwide consumer access
to safe, effective, and high quality products.
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B. International Agreements
The U.S. Government is a party to a number of international trade
agreements. FDA has participated in a number of recent international
trade negotiations to ensure that under such agreements, FDA regulatory
practices can remain focused on fulfilling the agency's mission to
protect the public health while being supportive of emerging, broader
U.S. Government trade obligations and policies.
One of the agreements that emerged from the recent General
Agreement on Tariffs and Trade (GATT) Uruguay Round of Multilateral
Trade Negotiations is the Agreement on the Application of Sanitary and
Phytosanitary Measures (SPS agreement, Ref. 2). This agreement governs,
among other things, measures intended: (1) To protect human or animal
life or health within a territory from risks arising from additives,
contaminants, toxins, or disease-causing organisms in foods, beverages,
or feedstuffs; and (2) to protect human life or health within a
territory from risks arising from diseases carried by animals, plants,
or products thereof.
The SPS agreement requires that members of the World Trade
Organization (WTO),\1\ when establishing their own SPS measures,
consider international standards, guidelines, or recommendations. A
country is not required to use an international standard, but must have
scientific justification to establish or maintain a more stringent
measure to meet the country's chosen level of protection if that
measure will impact on trade. As discussed in section II.B of this
document, standards established by Codex regarding food and substances
in food have a particular status under the SPS agreement.
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\1\ The Final Act of the GATT Uruguay Round in 1993 and the
Ministerial Meeting in Marrakesh in 1994 established the WTO.
Agreements concluded during the GATT Uruguay Round Negotiations are
to be administered by the WTO.
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A second relevant international agreement is the Agreement on
Technical Barriers to Trade (TBT agreement, Ref. 3). The TBT agreement
is intended to promote use by countries of standards, technical
regulations, and conformity assessment procedures that are based on
work done by international standard-setting bodies. In the TBT
agreement, the term ``standard'' is defined as follows:
A document approved by a recognized body that provides, for
common and repeated use, rules, guidelines or characteristics for
products or related processes and production methods, with which
compliance is not mandatory. It may also include or deal exclusively
with terminology, symbols, packaging, marking or labeling
requirements as they apply to a product, process or production
method.
Thus, FDA's stated policy on international standards and the
nation's obligations under the WTO provide compelling impetus for FDA
to consider whether to revise its existing system for review and
evaluation of international food standards, and if so, how such a
revised system might be designed.
II. Codex Alimentarius Commission
A. Codex Committees and U.S. Codex
Codex was created in 1962 by two United Nations organizations, FAO
and WHO. The dual purpose of Codex is to protect the health of
consumers and to ensure fair international trade in food. Codex
currently has over 150 members. Codex elaborates numerical standards,
codes of practice, and other guidelines through its committees (which
include committees related to specific commodities and committees
dealing with cross-cutting general subject areas) and promotes
acceptance\2\ and implementation of its standards by national
Governments. Each committee is chaired by a host member country.
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\2\ Standards adopted by Codex are currently subject to various
degrees of ``acceptance'' by national Governments using terms
defined by Codex. Such terms as ``full acceptance'', ``non-
acceptance'', and ``free distribution'' are currently employed to
describe an importing country's intent to accept or reject an import
shipment based on its compliance or noncompliance with applicable
Codex standards. These terms of acceptance are currently under
review by the Codex Committee on General Principles in order to
update and refine them relative to the recent SPS and TBT
agreements. The terms, per se, are not considered in this notice.
Thus, the terms ``accept'' and ``acceptance'', as used in this
document, are not intended to adhere to existing Codex definitions,
practices, or procedures.
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Codex currently has 8 general subject and 15 commodity committees.
The general subject committees and their host countries are: (1) Food
Labelling (Canada), (2) Food Additives and Contaminants (The
Netherlands), (3) Food Hygiene (The United States), (4) Pesticide
Residues (The Netherlands), (5) Residues of Veterinary Drugs in Foods
(The United States), (6) Methods of Analysis and Sampling (Hungary),
(7) Food Import and Export Inspection and Certification Systems
(Australia), and (8) General Principles (France). The General
Principles Committee oversees, maintains, and manages the Codex
procedural rules.
The general subject committees work closely with scientific bodies
established by FAO and WHO in developing Codex recommendations and
standards. For example, the Joint Expert Committee on Food Additives
(JECFA) and the Joint Meeting on Pesticide Residues (JMPR) are
comprised of experts selected from member countries. JECFA and JMPR
provide scientific advice and consultation on matters relevant to
Codex's standard-setting activities. Specifically, JECFA advises the
Codex Committee on Food Additives and Contaminants and the Codex
Committee on Residues of Veterinary Drugs in Foods; JMPR advises the
Codex Committee on Pesticide Residues. These scientific advisory bodies
do not themselves establish Codex standards, but they provide the
independent scientific review and scientific judgment necessary to
assist the Codex committees with development of such standards.
In addition to the 8 general subject committees, there are 15
commodity committees,\3\ of which 8 are still active. The active
commodity committees and their host countries are: (1) Fish and Fishery
Products (Norway), (2) Nutrition and Foods for Special Dietary Uses
(Germany), (3) Fresh Fruits and Vegetables (Mexico), (4) Milk and Milk
Products (New Zealand), (5) Fats and Oils (The United Kingdom), (6)
Cocoa Products and Chocolate (Switzerland), (7) Natural Mineral Waters
(Switzerland),\4\ and (8) Processed Fruits and Vegetables (The United
States).
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\3\ Seven Codex commodity committees, having completed their
current program of work, have been adjourned for the time being. One
former committee, the Codex Committee on Meat, has been dissolved.
The Codex commodity committees that have adjourned are: (1) Meat
Hygiene; (2) Sugars; (3) Soups and Broths; (4) Edible Ices; (5)
Vegetable Proteins; (6) Processed Meat and Poultry Products; and (7)
Cereals, Pulses, and Legumes.
\4\ This Committee was established by Codex as a Regional
(European) Committee, but has since been allocated the task of
elaborating world-wide standards for natural mineral waters.
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The Codex commodity committees and general subject committees work
cooperatively in that they consult one another on issues and defer
particular issues to the committee with most appropriate authority and
technical expertise.\5\
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\5\ In addition to the committees, there are five regional
coordinating committees (Africa, Asia, Europe, Latin America and the
Caribbean, and North America and the Southwest Pacific). The purpose
of the regional coordinating committees is to ensure that the
Codex's work is responsive to regional interests, particularly to
developing countries within each geographic region.
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Since 1962, Codex has produced numerous standards, guidelines,
codes of practice, and recommendations, including food commodity
standards and general subject food standards. In the course of its
work, Codex has evaluated the safety of over 500 food additives and
contaminants and set maximum residue limits for
Page 36245
approximately 2,500 pesticide/commodity combinations. Codex has adopted
maximum residue limits for 15 veterinary drugs.
The United States participates in Codex through U.S. Codex. U.S.
Codex consists of Federal Government officials representing several
Federal agencies, including FDA, and is assisted by representatives of
industry and consumer non-government organizations (NGO's).
Representatives of the United States have participated in deliberations
of Codex since its inception in 1962. The United States sends
delegations to participate in all Codex commodity and general subject
committee meetings. FDA, through its participation on most Codex
committees, provides scientific and regulatory expertise and conveys
agency views on various matters concerning Codex standards, from
elaboration to adoption. FDA officials also participate as independent
experts on JECFA.
In a notice published in the Federal Register of June 4, 1996 (61
FR 28132), the Food Safety and Inspection Service (FSIS) of the U.S.
Department of Agriculture (USDA), the lead Federal agency for
coordination of U.S. Codex activities,\6\ published the most recent
annual summary of standards under consideration or planned for
consideration by Codex to solicit input from persons and organizations
on these standards. This annual notice is required by the Trade
Agreements Act, as amended by the Uruguay Round Agreements Act, 108
Stat. 4809 (1994).
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\6\ Section 491 of the Trade Agreements Act of 1979, as amended
by the Uruguay Round Agreements Act, Public L. 103-465, 108 Stat.
4809 (1994) requires an annual notice of Codex activities.
Presidential Proclamation No. 6780 (60 FR 15845, March 23, 1995)
designates USDA/FSIS as the agency responsible for coordinating U.S.
Codex activities.
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Future annual notices by USDA/FSIS will continue to inform
interested parties of matters before the various Codex committees. This
mechanism provides the public with comprehensive and current
information, in one place, on all Codex activities and facilitates
public participation in the Codex standard-setting process. Thus,
through various U.S. Codex outreach activities such as pre- and post-
session briefings for the public, mailings, and the opportunity for
direct participation by NGO's on U.S. Codex delegations, interested
persons and organizations can contribute substantively to the
elaboration and eventual adoption of Codex standards.
B. Role of Codex Standards Under the SPS and TBT Agreements of the WTO
For the past 6 years, Codex has been engaged in a process of
revising a large proportion of its standards. In March 1991, in
anticipation of the changing status of Codex standards under the SPS
and TBT agreements then being negotiated in the GATT Uruguay Round, WHO
and FAO, in cooperation with GATT, sponsored the FAO/WHO Conference on
Food Standards and Chemicals in Food and Food Trade. This 1991
Conference in Rome (Ref. 4, ALICOM 91/22, FAO, WHO, GATT, Rome 1991)
made a number of recommendations on how the then-existing Codex
standard-setting process could be improved to better meet the
anticipated role of Codex standards under the SPS and TBT agreements.
The Rome meeting anticipated the SPS agreement's reference to, and
reliance upon, international standards, guidelines, and
recommendations, specifically those elaborated by Codex (SPS agreement
introductory statements, Art. 3.4, and Annex A, 3.a). Although the TBT
agreement does not specifically refer to Codex standards, Codex does
qualify as an international standard-setting body under the TBT
agreement when Codex elaborates and adopts international standards not
related to SPS food safety matters. Thus, the provisions of some Codex
standards fall within the terms of the TBT agreement.
Among the Conference's more significant recommendations intended to
position Codex to meet its anticipated role were several that addressed
streamlining existing Codex standards and the process by which new
standards are developed. Specifically, the Conference recommended that
Codex move toward a more horizontal approach to standard-setting, i.e.,
away from detailed, commodity-specific standards and toward more
broadly applicable, general subject standards. The Conference also
recommended that standards adopted include only those provisions
necessary for consumer protection, particularly those related to health
and food safety.
Most recommendations made by the Conference were subsequently
adopted by Codex at its 19th session in 1991. At its 20th session in
1993, Codex adopted a Medium Term Program of Work for 1993 to 1998
(Medium Term Plan, Ref. 5, ALINORM 93/38 and Addenda) which outlines
the anticipated standard-setting activities of Codex (including
numerical standards and related texts) over the next 5 years and
incorporates the 1991 Conference recommendations.
III. Possible FDA Strategy for Review of Codex Standards
In 1973, FDA established a regulation describing the process for
the review of commodity standards adopted by Codex (Secs. 130.6 and
564.6 (21 CFR 130.6 and 564.5)).\7\ These regulations apply only to
Codex commodity standards for human and animal foods, respectively, and
not to Codex general subject standards such as numerical standards for
chemical contaminants in foods or codes of practice for employing food
hygiene procedures. Currently, the agency has no process defined by
regulation for the consideration of general subject, also known as
horizontal, standards. FDA is considering revising its regulations to
accommodate agency review and acceptance of Codex general subject
standards. It is important to note that the Codex Committee on General
Principles at its November 1996 session recognized that all Codex
standards and related texts, including maximum residue limits, codes of
practice, and guidelines fall under the SPS rubric of international
standards, guidelines, and recommendations. Therefore, FDA has
tentatively concluded that the agency should have a procedure for
review of all Codex standards falling within its purview.
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\7\ This regulation was originally issued as 21 CFR 10.8 and was
redesignated subsequently as Secs. 130.6 (Part 130--Food Standards:
General) and 564.6 (Part 564--Definitions and Standards for Animal
Food).
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The agency is considering devoting substantial effort toward the
review and evaluation of Codex standards, perhaps focusing on those
standards adopted since 1993 and presented in the Medium Term Plan. It
may, however, be appropriate to consider the review of some pre-1993
Codex standards, for example, when: (1) An interested party petitions
the agency to accept a pre-1993 Codex standard and provides information
to enable a review, (2) the agency plans to issue a new FDA regulation
(or revise an existing regulation) and an existing Codex standard is
relevant to the new regulation,\8\ or (3) the United States is
Page 36246
challenged in an international trade situation where another country
cites as supporting information an existing Codex standard.
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\8\ As an example of this type of situation, current FDA
standards of identity regulations are often very specific for
particular foods. Virtually all of these standards of identity
regulations were established prior to the passage of the Nutrition
Labeling and Education Act of 1990 (Pub. L. 101-535, November 8,
1990) (the 1990 NLEA amendments) and thus, were developed without
reference to the significant informational function that a food
label can play. For example, prior to the 1990 amendments,
standarized foods were not required to bear complete ingredient
labeling. In light of this and other factors, FDA published an
Advance Notice of Proposed Rulemaking (60 FR 67492, December 29
,
1995) announcing that the agency intends to review its regulations
pertaining to identity, quality, and fill of container for
standardized foods with the intent of simplifying the regulations
where practicable and taking into account the impact of the 1990
NLEA amendments.
As part of any rulemaking growing out of the December 1995 ANPR,
and in keeping with FDA's obligations under international trade
agreements to consider Codex standards whenever the agency develops
or revises regulations, FDA intends to review corresponding Codex
commodity standards (including those adopted before 1993)
concurrently with its planned review and evaluation of FDA standards
pertaining to identity, quality, and fill of container and to
determine whether the corresponding provisions in the Codex standard
should be incorporated entirely or partially into any revised FDA
standard. In this context, it should be noted that FDA has not yet
determined the best means for streamlining domestic commodity
standards and the eventual approach chosen for evaluation of
relevant Codex standards will depend significantly on this
determination.
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IV. Request for Information
A. FDA's Possible Strategy for Consideration of Codex Standards
FDA notes that, faced with competing food safety priorities, it may
not be able to devote the resources necessary to fulfill all of its
responsibilities in an efficient and timely manner. In light of this,
FDA invites general comment on the relative importance of its Codex
activities in comparison to its other food safety and regulatory
responsibilities. In particular, FDA requests comments on the following
questions:
1. What is the appropriate priority of the agency's activities in
Codex in light of U.S. obligations under the WTO?
2. How might FDA enhance its ability to fulfill its broad public
health mandate through judicious acceptance and use of Codex standards?
3. Are there reasons that the agency should not expend resources in
the review and consideration of Codex standards?
4. If there are reasons that FDA should not expend resources on the
review of Codex standards, are these reasons compelling considering
U.S. obligations under the WTO?
5. How can review of Codex standards be incorporated efficiently
into current FDA standard setting processes?
6. Can resource savings be achieved without compromising consumer
protection?
If the agency concludes that it is appropriate to propose to revise
its regulations to accommodate consideration of Codex standards, FDA
plans to develop and publish a proposal outlining specific revisions.
To facilitate the agency's consideration of possible alternative
approaches, FDA requests comments on the following questions:
1. What revisions to existing FDA regulations or what new
regulations are appropriate?
2. If the agency eventually does undertake systematic review of
Codex standards, FDA is faced with deciding on how best to proceed with
review and evaluation of many newly adopted and some existing Codex
standards with regard to the acceptability of such standards relative
to existing FDA standards. What factors should the agency consider to
guide its priority setting and the efficient review and evaluation of
these Codex standards during any such review?
Codex standards adopted since 1993 reflect strengthening of the
standard setting process to enhance consumer protection and to
accommodate the more prominent role of Codex standards under the SPS
and TBT agreements. Because Codex standards adopted from 1993 forward
are intended to reflect the new role of Codex standards under the WTO
trade agreements, FDA is considering focusing its resources for review
of Codex standards on those standards adopted since 1993 as articulated
in the Codex Medium Term Plan and in its future updates. In this
context, FDA requests comments on the following questions:
1. Should FDA give priority to those Codex standards adopted since
1993?
2. Alternatively, should FDA attempt systematic review of all
existing Codex standards?
3. What are the resource implications of an approach requiring
review of all existing Codex standards?
4. Are there cost-efficient means for FDA to review all Codex
standards?
5. If only certain pre-1993 Codex standards merit consideration for
review by FDA, what circumstances would warrant FDA consideration of a
pre-1993 Codex standard?
6. How do existing Codex standards currently affect U.S. imports
and exports?
7. Are there specific Codex standards that have significant trade
impacts?
8. Are there specific Codex standards that are of particular
importance due to safety or other concerns?
9. In the case of a person or organization that specifically
petitions FDA to review a particular Codex standard, how might FDA best
guide the petitioner to submit appropriate background information?
Should FDA encourage the submission of draft language that could be
used as a basis for a proposed FDA regulation governing the par
ticular
issue?
10. What are the potential benefits and costs to U.S. consumers and
businesses of FDA consideration, acceptance and use of some specific
Codex standards?
11. What costs are associated with researching and summarizing
information necessary to compare a Codex standard with an FDA standard?
How do these costs vary according to the complexity of the standard?
Upon consideration of a Codex standard, FDA believes that it will
be faced with the following four situations with regard to standards
that the agency believes to be suitable for FDA acceptance: (1) The
standard is substantively identical to FDA's regulations; (2) the
standard is similar but not identical to FDA's regulations; (3)
although the standard is not identical or similar to FDA's regulations,
FDA wishes to propose to accept the Codex standard to further its
public health mission and such acceptance will require rulemaking under
the Federal Food, Drug, and Cosmetic Act (the act); (4) or the standard
is not identical to or similar to any FDA regulation, and the adoption
of the Codex standard is not subject to rulemaking under the act. In
addition to these four situations where the agency might wish to accept
a Codex standard, FDA might wish, instead, to reject a particular Codex
standard because the standard fails to provide the appropriate level of
protection for U.S. consumers.
There are various procedural approaches that the agency might use
to address these situations. In a case where a Codex standard is
essentially identical to an FDA regulation, the agency might elect only
to publish a Federal Register notice recognizing the substantive
equivalence of the Codex standard to FDA's standard. Where a Codex
standard is very similar, but not identical, to an FDA standard, the
agency might publish a proposal for comment to amend FDA's regulations
slightly to bring the agency's regulations into conformity with the
Codex standard. More complex proposals and associated rulemaking would
likely be required when FDA wishes to accept a Codex standard that is
substantively different from an FDA regulation, but that the agency
believes would provide a greater degree of public health protection
than an existing FDA standard. Such a situation would likely entail
significant revision to the existing FDA regulation with corresponding
greater opportunities for public comment on the proposed, subst
antive
revisions.
In light of the need for FDA to accomplish any review,
consideration, and determination of acceptability of Codex standards in
as efficient a manner as possible, and recognizing that there
Page 36247
are a large number of Codex standards that may vary greatly in their
complexity and their actual impact on U.S. public health protection,
FDA invites comments on approaches the agency might employ to achieve
the most resource-efficient reviews.
FDA is considering amending its current regulations by removing
Secs. 130.6 and 564.6 and establishing a new section to describe
procedures that the agency would use when it considers Codex standards
for acceptance. To date, FDA has identified the following goals for the
proposed amendments it is considering: (1) To be certain that a
ny
process used by FDA for reviewing standards adopted by Codex ensures
that food conforming to a Codex standard is safe within the meaning of
the act, (2) to ensure that FDA's review and consideration of Codex
standards is transparent and science-based, (3) to clarify the
procedures for FDA's consideration of commodity and general subject
standards adopted by Codex, (4) to clarify when rulemaking is necessary
as part of the agency's consideration of a standard adopted by Codex,
and (5) to ensure that FDA's regulations for consideration of Codex
standards are appropriate for all Codex standards and related texts.
The agency seeks comment on whether to proceed with a proposal to
establish new regulations governing agency consideration of Codex
standards. What goals, in addition to those listed previously, should
be considered by the agency in developing any new regulations governing
consideration of Codex standards?
B. Public Participation
1. FDA Notice of Newly Adopted Codex Standards
In the event that FDA proposes to establish a systematic review and
evaluation procedure for Codex standards, the agency has tentatively
concluded that it would be important to establish a mechanism to
solicit active public participation in its consideration of such
standards. Therefore, the agency is considering what procedures,
including notice and comment procedures, could be utilized that would
be appropriate, efficient, and would facilitate review, evaluation, and
public notification of agency determinations regarding Codex standards.
One approach under consideration is to have FDA, after each meeting of
the Codex Alimentarius Commission, announce publicly those standards,
codes of practice, guidelines, and related texts adopted by Codex at
that session that fall within FDA's jurisdictional areas. This could be
accomplished through notice in the Federal Register announcing adoption
by Codex of the standard(s) and requesting interested parties to
provide FDA with pertinent information and comments concerning the
particular Codex standard(s).
Under such an approach, the Federal Register notice could:
1. Describe the nature of the Codex standard and its comparability
to an FDA regulation or another measure;
2. Provide FDA's preliminary views on the Codex standard's
provisions, including its potential for acceptance by FDA, and whether
rulemaking would be necessary;
3. Describe information the agency would need for adequate
evaluation of the standard;
4. Invite interested persons to provide information relevant to the
evaluation of the standard and to the assessment of the relative
importance of the particular Codex standard(s) to public health
protection and international trade; and
5. State the agency's preliminary plans to perform substantive
review of the standard.
In light of any comments received in response to such a notice and
other available information bearing on the potential of the new Codex
standard to further FDA's public health mission, FDA would be better
positioned to determine the priority to attach to review and evaluation
of the standard(s) and would have sufficient information on which to
base an initial determination of whether to accept the new Codex
standard.
The agency seeks comment on whether a notice such as suggested in
this section is an appropriate means to notify the public initially of
the adoption of a standard by Codex. If not, what alternative approach
should be considered? Are any supplemental notification methods
appropriate and, if so, what methods? For example, should the agency
consider complementary notification mechanisms such as use of internet
sites or public meetings? Is there information (in addition to that
identified previously) that an initial public notice should contain?
2. Enlisting Assistance of Expertise Outside of FDA
The potentially large number of standards that may emerge from the
Codex process requires the agency to consider alternatives for
providing adequate resources for the review of Codex standards,
particularly in identifying expertise in a specific subject or
commodity area.
One possible approach to facilitate the review process is to enlist
expertise outside of FDA to participate actively in the technical
examination of Codex standards for the purpose of determining
similarities and differences between the Codex standards and FDA
standards. The agency has tentatively concluded that actively
soliciting outside technical assistance from industry, academia,
consumer representatives, and other interested persons with knowledge
and expertise in a given subject or product area should be considered
as an approach to cataloguing, performing technical comparisons,
setting priorities for review of new Codex standards, and perhaps
preparing draft documents that might serve as the basis for eventual
FDA regulations. FDA's current view is that such non-FDA expertise
would be used primarily for comparing the technical aspects of a Codex
standard and an FDA regulation, such as a side-by-side comparison.
To what extent, and how, should FDA utilize outside expertise such
as that which exists in the affected industries to assist with the task
of setting priorities for review of Codex standards and otherwise
facilitating agency evaluation of Codex standards? For example, both
the Codex commodity standards and FDA's food standards established
under section 401 of the act (21 U.S.C. 341) are currently being
reviewed and revised (60 FR 67492). Should FDA consider a process that
draws upon non-FDA expertise to assist with review of FDA standards of
identity regulations and Codex commodity standards? If so, how might
expertise outside of FDA be utilized to review existing Codex and FDA
standards, to assist FDA in establishing priorities for review of such
Codex standards relative to their importance in consumer protection and
the international trade for the particular commodity, and to prepare
detailed technical reports comparing the Codex and FDA standards? Are
there any limitations - legal, practical, or otherwise - on FDA's
utilization of such experts as part of any agency process established
to review and evaluate Codex standards? If so, what are those
limitations?
Are there any other circumstances besides the previous example in
which the utilization of non-FDA expertise could facilitate FDA's
review, evaluation, and acceptance of Codex standards? How can FDA
increase general participation of outside experts, including consumers,
industry representatives and others, in facilitating the agency's
setting of priorities and review of Codex
Page 36248
standards? What are the benefits and costs of participation by non-FDA
experts in the review and evaluation of Codex standards? Are there any
drawbacks to such participation by non-FDA experts in agency review of
Codex standards?
3. Assessing Impact on Small Business
The Regulatory Flexibility Act (Pub. L. 105-121 (5 U.S.C. 601-612))
requires agencies to analyze the impact of regulations on small
entities. How can FDA take into account the special concerns of small
businesses in FDA's consideration of Codex standards? What is the
likely impact on small entities of a program of formal review and
acceptance of Codex standards? What issues, if any, would have a
disproportionately large impact on small entities or would place small
entities at a disadvantage relative to large entities? Are there
particular features to a system for review and acceptance of Codex
standards that would minimize the impact on small entities?
C. Maintenance of Public File of FDA Determinations Regarding Codex
Standards
The agency anticipates that if a process for reviewing Codex
standards is adopted, FDA determinations in response to standards
adopted by Codex will be published in the Federal Register either by
notice or by rulemaking. The agency currently plans to maintain a
public docket pertinent to each such Federal Register publication. In
addition, FDA believes that it may be appropriate to provide copies of
all final FDA determinations regarding Codex standards to the Office of
the U.S Codex (FSIS/USDA) for maintenance in a public file. FDA
believes that the Office of the U.S. Codex is positioned to maintain
this information, along with Codex-related documents from other U.S.
Federal agencies, as a comprehensive record readily accessible by the
public. The agency specifically requests comments on this approach. In
addition, FDA requests comments on alternative approaches.
V. References
The following references have been placed on public display in the
Dockets Management Branch (address above) and may be seen by interested
persons between 9 a.m. and 4 p.m., Monday through Friday.
1. Procedural Manual, Codex Alimentarius Commission, Ninth Ed.,
Food and Agriculture Organization/World Health Organization, Rome
1995.
2. Agreement on the Application of Sanitary and Phytosanitary
Measures, in The Results of the Uruguay Round of Multilateral Trade
Negotiations--The Legal Texts, p. 69, World Trade Organization,
Geneva 1995.
3. Agreement on Technical Barriers to Trade, in The Results of
the Uruguay Round of Multilateral Trade Negotiations--The Legal
Texts, p. 138, World Trade Organization, Geneva 1995.
4. FAO/WHO Conference on Food Standards, Chemicals in Food and
Food Trade (in cooperation with GATT), vol. 1, Report of Conference,
ALICOM 91-22, FAO/WHO/GATT, Rome 1991.
5. Proposed Medium Term Plan for the Codex Alimentarius
Commission 1993-1998, ALINORM 93/38, Codex Alimentarius Commission
Twentieth Session, Geneva 1993.
Dated: June 10, 1997.
William B. Schultz,
Deputy Commissioner for Policy.
FR Doc. 97-17515 Filed 7-3-97; 8:45 am
BILLING CODE 4160-01-F
