[Federal Register Volume 64, Number 243 (Monday, December 20, 1999)]
[Notices]
[Pages 71145-71147]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-32787]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 99N-3089]
Affirmative Agenda for International Activities--Center for Food
Safety and Applied Nutrition, Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of the Center for Food Safety and Applied Nutrition's
(CFSAN) Affirmative Agenda for International Activities (International
Affirmative Agenda). CFSAN intends to use the general framework of 2000
to 2002 priorities identified in the International Affirmative Agenda
during its annual planning process to develop specific international
activities for each of the 3 years.
ADDRESSES: The International Affirmative Agenda is available for public
examination in the Dockets Management Branch (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm.1601, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: John W. Jones, Office of Constituent
Operations, Center for Food Safety and Applied Nutrition (HFS-550), 200
C St. SW., Washington, DC 20204, 202-205-4311.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of September 17, 1999 (64 FR 50518), FDA
announced the availability of CFSAN's Draft International Affirmative
Agenda for 2000 to 2002. FDA also solicited comments on whether to hold
a public meeting on the Draft International Affirmative Agenda.
Interested persons were given until October 1, 1999, to request a
public meeting and until November 1, 1999, to comment. The current
notice summarizes the comments received on the draft document and
announces the availability of the final version of CFSAN's
International Affirmative Agenda. CFSAN intends to use the general
framework of 2000 to 2002 priorities identified in the International
Affirmative Agenda during the center's annual planning process to
develop specific international activities. CFSAN also intends to
solicit public input on these planned international activities on an
annual basis. Therefore, there will be continuing opportunity for
public comment on CFSAN's planned international activities and on the
center's overall international priorities.
II. Summary of Comments
FDA received eight letters, each containing one or more comments,
on CFSAN's Draft International Affirmative Agenda from a consumer
group, a food and drug professional association, and six industry trade
associations. FDA received only one request for a public meeting and,
based on this, the agency determined that there was not sufficient
interest to conduct such a meeting. All of the substantive comments
strongly supported the goals of CFSAN's Draft International Affirmative
Agenda for 2000 to 2002. The comments articulated some concerns and
made a number of suggestions.
A number of comments were related to FDA's public health mandate,
the need for FDA to ensure that this mandate is not compromised by
trade concerns, and the suggested need for FDA to promote proactively
U.S. public health positions in deliberations of international standard
setting bodies.
Most, but not all, of these comments suggested that CFSAN only
participate in international activities that are consistent with and
directly responsive to FDA's mission to protect the public health that
is mandated explicitly by statute. Concern was expressed about possible
CFSAN activities that appear to promote a particular technology (e.g.,
biotechnology) or that pertain to equivalence or mutual recognition
agreements where, it was asserted, FDA's ability to protect public
health would be lowered. There was also concern about any CFSAN
activity related to the World Trade Organization (WTO) or North
American Free Trade Agreement (NAFTA) that is undertaken explicitly to
promote international trade at the expense of public health. The
suggestion also was made that CFSAN should oppose actively the
establishment of any standard by the Codex Alimentarius Commission
(Codex) that does not provide a level of consumer protection equivalent
to that which is provided by FDA regulation. One comment, however,
suggested that FDA should undertake international activities
specifically to support U.S. economic, trade, and market development
interests overseas.
Some comments recommended that CFSAN strengthen its participation
in Codex to ensure that Codex standards are based on sound scientific
principles. These comments emphasized that CFSAN should work closely
with the appropriate food industry representatives to develop
technically accurate U.S. positions on matters before Codex and to
ensure that Codex standards are practicable. The comments also
suggested that CFSAN's participation in the Codex development process
should be an agency priority and its delegates should be appropriately
trained to strengthen the agency's participation.
Likewise, comments suggested that CFSAN take a more proactive and
leadership role in developing appropriate work plans for the technical
working groups (TWG's) convened under the NAFTA Sanitary and
Phytosanitary (SPS) committee, particularly in the area of harmonized
regulation procedures for food additives, safety assessments for foods
derived from biotechnology, product recall and traceback procedures,
and harmonized NAFTA positions on issues before Codex. The agency also
was encouraged to be more actively involved in articulating the
strength of the U.S. food regulatory system within the WTO's SPS
committee.
FDA intends that all of CFSAN's international activities have as
their basis maintenance and enhancement of U.S. public health. The
draft International Affirmative Agenda states that consistency with
FDA's primary public health mission is the first guiding principle of
CFSAN's participation in any international activity. In this regard,
CFSAN intends to participate in international activities that are
intended, directly or indirectly, to enhance the safety, nutritional
quality and informative and truthful labeling of foods, and the safety
and labeling of cosmetics available to the American consumer, whether
the products are produced in or imported into the United States. CFSAN
also intends to participate, when practicable, in activities that
address other compelling international or domestic public health
issues, concerns or priorities identified by the Department of Health
and Human Services and other domestic and foreign public health
agencies that are important to CFSAN's areas of expertise and
authority.
FDA emphasizes that CFSAN's international activities, including
participation in committees of the Codex and other standard setting
bodies, are aimed primarily at enhancing the agency's ability to
protect
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U.S. public health. In all international areas where standards are
developed or decisions are made that bear on the safety and quality of
foods and cosmetics that are produced in or imported into the United
States, CFSAN intends to exercise leadership, authority, and influence
to ensure that American consumers are protected by such standards and
decisions. With regard specifically to bilateral agreements, FDA
intends to enhance its ability to ensure that foods and cosmetics
imported into the United States are safe through development of formal
agreements with foreign governments, such as equivalence agreements,
mutual recognition agreements, and memoranda of understanding, that are
intended to provide FDA with reasonable assurance that products covered
by such agreements consistently meet the U.S. level of public health
protection.
CFSAN does not intend to undertake trade-related activities that
are intended solely to promote U.S. trade interests or that have the
effect of diminishing U.S. public health protection. CFSAN believes
that it is appropriate, however, for the center to participate, where
practicable, in international activities conducted in response to U.S.
obligations under international treaties, trade agreements and other
recognized, formal or informal arrangements of the United States. These
activities include situations where CFSAN's participation is critical
to help the United States resolve international trade disputes or
preclude trade interruptions associated with foods and cosmetics for
which FDA is the recognized competent U.S. authority.
Other comments were more specific in nature and related to the
particular interests of the commenting organization. One comment
generally supported CFSAN's proposed international priorities and
indicated that the proposed activities, if implemented fully, would
enhance FDA's ability to protect public health. The comment stated that
the particular organization, which represents Federal, State, and local
food and drug officials in the United States and Canada, is well
positioned to work cooperatively with FDA and CFSAN, specifically, to
implement CFSAN's international activities. In particular, the
organization stated that a number of States represented by the
association are willing to work collaboratively with FDA through
Federal-State partnership agreements which, among other activities,
might monitor imported foods to determine compliance with U.S.
requirements, assist with trace backs of outbreaks of foodborne
illnesses to their source, and improve compliance of imported foods
with U.S. labeling requirements. The comment encouraged FDA to pursue
additional partnerships with the states to help accomplish the
regulatory and enforcement components of the CFSAN's international
priorities and to work with the association to facilitate development
of such partnerships.
FDA recognizes the continuing importance and advantages of working
with state and local authorities on critical food and cosmetic issues,
both domestic and international. The agency intends to work
collaboratively with state and local regulatory officials through
formal Federal-State partnerships and other approaches to leverage
expertise and resources. The agency appreciates the organization's
willingness to facilitate such collaboration with regard to imported
foods and will consider means of enhancing cooperative activities in
this area.
Additional comments stressed the importance of FDA finalizing its
criteria for determining the equivalence of foreign food regulatory
systems so that the United States can deal effectively and efficiently
with diverse foreign regulatory systems. The agency was encouraged, for
example, to conclude an equivalence agreement with Canadian authorities
regarding fish and fishery inspection systems.
FDA intends to finalize its equivalence criteria for foods as soon
as possible and to use the final criteria in future equivalence
evaluations of foreign food safety regulatory systems.
Two comments strongly supported continuation of cosmetic industry
trade association involvement in issuance of export certificates. The
comments encouraged FDA to continue to permit cosmetic trade
associations to issue export certificates on behalf of members, citing
the time efficiency of the industry's program relative to that of any
corresponding government certificate issuance activity. Conversely,
another comment expressed the view that equivalence agreements,
memoranda of understanding, and mutual recognition agreements should be
developed between FDA and its trading partners as a means of reducing
the need for export certificates.
FDA is currently examining the issue of the agency's involvement
in issuance of export certificates for U.S.-produced foods and
cosmetics.FDA also intends to finalize its equivalence criteria for
foods as soon as possible. The agency will consider the associations'
comments during its consideration of the agency's role in issuance of
export certificates and whether any future equivalence agreements might
reduce foreign requirements for such certificates.
One comment strongly encouraged CFSAN to participate in all
relevant international discussions concerning development of harmonized
international standards for cosmetics, particularly those discussions
bearing on cosmetic trade among the United States, Canada, the European
Union, and Japan. Other comments supported CFSAN's continuing
involvement in development of mutual recognition agreements pertaining
to cosmetics and provision of technical assistance to U.S. trade
agencies to prevent or resolve trade disputes involving cosmetics. The
comments also supported CFSAN's proposed priority to seek alternatives
to animal testing for cosmetics.
CFSAN intends to participate, within resource constraints, in
relevant international discussions concerning the safety and labeling
of cosmetics to work to harmonize scientific and regulatory approaches,
where such harmonization is practicable and maintains or enhances U.S.
public health protection.
Two of the food trade associations commented that FDA should
strengthen its participation in TWG's convened under NAFTA Sanitary and
SPS committee in order to take a more proactive role in developing
appropriate work plans for these groups. Specifically, one comment
suggested that the TWG's could facilitate issues pertaining to
harmonized registration procedures for food additives, safety
assessments for foods derived from biotechnology, product recall and
trace back procedures, and harmonized NAFTA positions on issues before
Codex. This comment noted that FDA had not utilized the TWGs fully and
encouraged CFSAN to undertake a greater leadership role in the TWGs.
Two of the associations also encouraged FDA to become more actively
involved in issues before the WTO's SPS committee, particularly with
regard to articulating the strengths of the U.S. food regulatory
system.
FDA agrees that the NAFTA TWG's provide an appropriate forum to
address food safety, quality and labeling issues that are of interest
to Canada, Mexico, and the United States. The agency also agrees that
these TWG's can have a positive impact on public health protection and
facilitation of the trade of safe food products among the three
countries. CFSAN intends to strengthen its participation and leadership
in these NAFTA TWG's to the extent practicable. CFSAN also intends to
continue its participation in the WTO SPS
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committee in order to promote and enhance public health protection in
this forum.
Other comments by the food trade associations related to FDA and
CFSAN resources needed to accomplish the proposed international
priorities, the need for CFSAN to develop a more detailed list of
specific activities within each of the broad priority areas in the
draft International Affirmative Agenda, and a suggestion that CFSAN's
``first'' priority, both in its domestic and international activities,
should be development, maintenance, and dissemination of its science
base. Finally, several comments stressed that CFSAN should strive to
involve the public fully in its international activities through
appropriate notice and comment opportunities and other means.
III. Final CFSAN International Affirmative Agenda for 2000 to 2002
FDA appreciates the comments submitted by the eight organizations
and recognizes that all of the comments have merit with regard to
CFSAN's current and future international activities. The agency agrees,
in principle, with most of the comments and believes that the
priorities that CFSAN has articulated in its draft International
Affirmative Agenda are compatible with all of the comments.
The international priorities as expressed in the International
Affirmative Agenda represent a general framework for the center's
international activities for 2000 to 2002. Many specific activities
within the broader priority areas are to be planned and accomplished by
the center on an annual basis over the next 3 years. Therefore, as
these specific, annual international activities are identified and
developed, CFSAN will solicit and consider additional public comments,
in addition to those submitted on the draft International Affirmative
Agenda.
Based on CFSAN's intent to consider comments on its specific
international activities on an annual basis during development of its
annual international program priorities, the center has elected to
finalize CFSAN's International Affirmative Agenda without any changes
from the original draft text.
Dated: December 10, 1999.
Margaret M. Dotzel,
Acting Associate Commissioner for Policy.
[FR Doc. 99-32787 Filed 12-15-99; 8:59 am]
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