[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

[[Page 71147]]

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]
BILLING CODE 4160-01-F