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International Sanitary and Phytosanitary Standard-Setting Activities
Note: EPA no longer updates this information, but it may be useful as a reference or resource.
[Federal Register: August 17, 2001 (Volume 66, Number 160)]
[Notices]
[Page 43171-43177]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr17au01-41]
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Notices
Federal Register
________________________________________________________________________
This section of the FEDERAL REGISTER contains documents other than rules
or proposed rules that are applicable to the public. Notices of hearings
and investigations, committee meetings, agency decisions and rulings,
delegations of authority, filing of petitions and applications and agency
statements of organization and functions are examples of documents
appearing in this section.
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DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
[Docket No. 01-046-1]
International Sanitary and Phytosanitary Standard-Setting
Activities
AGENCY: Animal and Plant Health Inspection Service, USDA.
ACTION: Notice and request for comments.
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SUMMARY: In accordance with legislation implementing the results of the
Uruguay Round of negotiations under the General Agreement on Tariffs
and Trade, we are informing the public of international standard-
setting activities of the Office International des Epizooties, the
Secretariat of the International Plant Protection Convention, and the
North American Plant Protection Organization, and we are soliciting
public comment on the standards to be considered.
ADDRESSES: Please send four copies of your comments (an original and
three copies) to: Docket No. 01-046-1, Regulatory Analysis and
Development, PPD, APHIS, Suite 3C03, 4700 River Road Unit 118,
Riverdale, MD 20737-1238.
Please state that your comment refers to Docket No. 01-046-1.
You may read any comments that we receive on this docket in our
reading room. The reading room is located in room 1141 of the USDA
South Building, 14th Street and Independence Avenue SW., Washington,
DC. Normal reading room hours are 8 a.m. to 4:30 p.m., Monday through
Friday, except holidays. To be sure someone is there to help you,
please call (202) 690-2817 before coming.
APHIS documents published in the Federal Register, and related
information, including the names of organizations and individuals who
have commented on APHIS dockets, are available on the Internet at
http://www.aphis.usda.gov/ppd/rad/webrepor.html.
FOR FURTHER INFORMATION CONTACT: For general information on the topics
covered in this notice, contact Mr. John Greifer, Director, Trade
Support Team, International Services, APHIS, room 1132, South Building,
14th Street and Independence Avenue SW., Washington, DC 20250; (202)
720-7677. For specific information regarding standard-setting
activities of the Office International des Epizooties, contact Dr.
Michael David, Chief, Sanitary International Standards Team, VS, APHIS,
4700 River Road Unit 33, Riverdale, MD 20737-1231; (301) 734-8093. For
specific information regarding the standard-setting activities of the
International Plant Protection Convention or the North American Plant
Protection Organization, contact Mr. Narcy Klag, Program Manager,
Phytosanitary Issues Management, PPQ, APHIS, 4700 River Road Unit 60,
Riverdale, MD 20737-1236; (301) 734-8469.
SUPPLEMENTARY INFORMATION: The World Trade Organization (WTO) was
established as the common international institutional framework for
governing trade relations among its members in matters related to the
Uruguay Round Agreements. The WTO is the successor organization to the
General Agreement on Tariffs and Trade. U.S. membership in the WTO was
approved by Congress when it enacted the Uruguay Round Agreements Act
(Pub. L. 103-465), which was signed into law by the President on
December 8, 1994. The WTO Agreements, which established the WTO,
entered into force with respect to the United States on January 1,
1995. The Uruguay Round Agreements Act amended title IV of the Trade
Agreements Act of 1979 (19 U.S.C. 2531 et seq.). Section 491 of the
Trade Agreement Act of 1979, as amended (19 U.S.C. 2578), requires the
President to designate an agency to be responsible for informing the
public of the sanitary and phytosanitary (SPS) standard-setting
activities of each international standard-setting organization. The
designated agency must inform the public by publishing an annual notice
in the Federal Register that provides the following information: (1)
The SPS standards under consideration or planned for consideration by
the international standard-setting organization; and (2) for each SPS
standard specified, a description of the consideration or planned
consideration of that standard, a statement of whether the United
States is participating or plans to participate in the consideration of
that standard, the agenda for U.S. participation, if any, and the
agency responsible for representing the United States with respect to
that standard.
``International standard'' is defined in 19 U.S.C. 2578b as any
standard, guideline, or recommendation: (1) Adopted by the Codex
Alimentarius Commission (Codex) regarding food safety; (2) developed
under the auspices of the Office International des Epizooties (OIE)
regarding animal health and zoonoses; (3) developed under the auspices
of the Secretariat of the International Plant Protection Convention
(IPPC) in cooperation with the North American Plant Protection
Organization (NAPPO) regarding plant health; or (4) established by or
developed under any other international organization agreed to by the
member countries of the North American Free Trade Agreement (NAFTA) or
the member countries of the WTO.
The President, pursuant to Proclamation No. 6780 of March 23, 1995
(60 FR 15845), designated the Secretary of Agriculture as the official
responsible for informing the public of the SPS standard-setting
activities of Codex, OIE, IPPC, and NAPPO. This responsibility was
delegated to the United States Department of Agriculture's (USDA's)
Food Safety and Inspection Service (FSIS) for Codex activities and
Animal and Plant Health Inspection Service (APHIS) for OIE, IPPC, and
NAPPO activities.
FSIS is responsible for publishing an annual notice in the Federal
Register to inform the public of SPS standard-setting activities for
Codex. Codex was created in 1962 by two United Nations organizations,
the Food and Agriculture Organization (FAO) and the World Health
Organization. It is the major international organization for
encouraging international trade in food and protecting the health and
economic interests of consumers.
APHIS is responsible for publishing notice of OIE, IPPC, and NAPPO
activities related to international standards and for representing the
[[Page 43172]]
United States with respect to these standards.
Following are descriptions of the OIE, IPPC, and NAPPO
organizations and the standard-setting agenda for each of these
institutions. We have described the agenda that each of these
organizations will address at their annual general sessions, including
standards that may be presented for adoption or consideration, as well
as other initiatives that may be underway at the OIE, IPPC, and NAPPO.
The agendas for these meetings are subject to change, and the draft
standards identified in this notice may not be sufficiently developed
and ready for adoption as indicated. Also, while it is the intent of
the United States to support adoption of international standards and to
participate actively and fully in their development, it should be
recognized that the U.S. position on a specific draft standard will
depend on the acceptability of the final draft. Given the dynamic and
interactive nature of the standard-setting process, we encourage any
persons who are interested in the most current details about a specific
draft standard or the U.S. position on a particular standard-setting
issue, or in providing comments on a specific standard that may be
under development, to contact APHIS. Contact information is provided at
the beginning of this notice under FOR FURTHER INFORMATION CONTACT.
OIE Standard-Setting Activities
The OIE was established in Paris, France, in 1924 with the signing
of an international agreement by 28 countries. It is currently composed
of 157 member nations, each of which is represented by a delegate who,
in most cases, is the chief veterinary officer of that country. The WTO
has recognized the OIE as the international forum for setting animal
health standards, reporting global animal situations and disease
status, and presenting guidelines and recommendations on sanitary
measures relating to animal health.
The OIE facilitates intergovernmental cooperation to prevent the
spread of contagious diseases in animals by sharing scientific research
among its members. The major functions of the OIE are to collect and
disseminate information on the distribution and occurrence of animal
diseases and to ensure that scientifically justified standards govern
international trade in animals and animal products. The OIE aims to
achieve this through the development and revision of international
standards for diagnostic tests, vaccines, and the safe international
trade of animals and animal products.
The OIE provides annual reports on the global distribution of
animal diseases, recognizes the free status of member countries for
certain diseases, categorizes animal diseases with respect to their
international significance, publishes bulletins on global disease
status, and provides animal disease control guidelines to member
countries.
The various OIE commissions and working groups undertake the
initial analysis and preparation of draft standards, which are then
circulated to member countries for consultation (review and comment).
Draft standards are revised accordingly and then presented to the OIE
General Session, which meets annually every May, for review and
adoption. Adoption, as a general rule, is based on consensus of the OIE
membership.
The next OIE General Session is scheduled for the third or fourth
week of May 2002 in Paris, France. The Deputy Administrator for APHIS'
Veterinary Services is the official U.S. delegate to the OIE. The
Deputy Administrator intends to participate in the proceedings and will
discuss or comment on APHIS' position on any standard up for adoption.
OIE Code Chapters Up for Adoption
Revisions to the following chapters of the OIE International Animal
Health Code are expected to be presented for adoption at the next
General Session in May 2002:
1. Scrapie: This is a disease of sheep and goats. This will
constitute a new chapter in the OIE Code. It will provide guidance for
safe trade in sheep and goats, including their products, with respect
to scrapie. The United States intends to support adoption of this new
Code chapter assuming it is ready for such consideration and is
consistent with our scientific knowledge of this disease.
2. Classical swine fever (CSF): This is a disease of hogs. This is
not a new chapter in the OIE Code. This chapter is being updated in
order to incorporate contemporary scientific knowledge about this
disease (e.g., new knowledge regarding surveillance for CSF, testing,
etc.). These changes may affect current OIE export certification
standards for products affected with CSF. The United States intends to
support this revised Code chapter assuming it is ready for such
consideration and is consistent with our scientific knowledge of this
disease.
3. Newcastle disease: This a poultry disease. This is not a new OIE
Code chapter. Changes are being made to this chapter to reflect
contemporary scientific knowledge about Newcastle disease (e.g., new
knowledge regarding surveillance for the disease, testing, etc.). These
changes may affect current OIE export certification standards for
products affected with Newcastle disease. The United States intends to
support adoption of this revised Code chapter assuming it is ready for
such consideration and is consistent with our scientific knowledge of
this disease.
4. Diseases of bees: This represents a revision to or updating of
an existing OIE Code chapter. This chapter, which addresses most
diseases of honeybees, including mites, will be revised to incorporate
changes in scientific knowledge about various honeybee diseases. This
chapter will continue to provide guidance for certifying honeybee
packages and queen bees for export purposes. The United States intends
to support adoption of this revised chapter assuming it is ready for
such consideration and is consistent with our scientific knowledge of
this disease.
5. Infectious Bursal Disease (IBD): This is a disease of poultry.
This existing chapter will be revised to incorporate contemporary
scientific knowledge about IBD (e.g., new knowledge regarding
surveillance for the disease, testing, etc.). These changes may affect
current OIE export certification standards for products that may be
affected with IBD. The United States intends to support adoption of
this revised Code chapter assuming it is ready for such consideration
and is consistent with our scientific knowledge of this disease.
As a matter of process, these chapters are drafted (or revised) by
ad hoc groups composed of technical experts nominated by the OIE Code
Commission by virtue of their subject-area expertise (not their
national affiliation). Once the ad hoc expert group completes its task
of drafting a new chapter or revising an existing one, it is then
distributed to member countries for review and comment. Typically, the
OIE distributes the proposed or revised Code chapters to its member
countries by late October of each year. The draft standard is revised
by the Code Commission on the basis of relevant scientific comments
received from member countries.
The United States (i.e., USDA/APHIS) intends to review and comment
on all draft chapter revisions once it receives them from the OIE, most
likely in late October or early November 2001. USDA/APHIS intends to
distribute these drafts to the U.S. livestock industry, veterinary
experts in various U.S. academic institutions, and other
[[Page 43173]]
interested persons for review and comment. These drafts are also posted
on a website maintained by the U.S. Animal Health Association (USAHA).
Hence, U.S. comments submitted to the OIE will be based on APHIS'
analysis and relevant scientific information received from various
domestic commenters. Additional information regarding these draft
standards may be obtained by contacting Dr. Michael David (see FOR
FURTHER INFORMATION CONTACT above).
Generally, if a country has concerns with a particular draft
standard, and supports those concerns with sound technical information,
the Commission will revise that standard accordingly and present the
revised draft for adoption at the General Session in May. In the event
that a country's concerns regarding a draft standard are not taken into
account, that country may refuse to support the standard when it comes
up for adoption at the General Session. However, each member country is
obligated to review, comment, and make decisions regarding the adoption
of standards strictly on their scientific merits.
OIE Future Work Program
In the next few years, the Code Commission is expected to establish
ad hoc groups of experts to update and/or develop the standards for the
following diseases:
1. Transmissible spongiform encephalopathy in small ruminants: This
would be a new OIE Code chapter intended to provide guidance for export
certification of sheep and goats and their products. The United States
will consider its position on this new standard after it reviews a
prepared draft.
2. Bovine tuberculosis: This would represent a revision of an
existing OIE Code chapter. Changes to this chapter are being considered
due to new scientific information about this disease. Changes to this
chapter could result in changes in the current export certification
standards for cattle. The United States intends to support adoption of
this new Code chapter assuming it is ready for such consideration and
is consistent with our scientific knowledge of this disease. The United
States will consider its position on this revised standard after it
reviews a prepared draft.
3. Paratuberculosis: This would represent a revision of an existing
OIE Code chapter. Changes to this chapter are being considered due to
new scientific information about this disease, primarily as it affects
cattle and sheep. The United States will consider its position on this
revised Code chapter after it reviews a prepared draft.
4. Chronic wasting disease: This is a disease of wildlife and farm-
raised animals, primarily deer and elk. This would be new OIE Code
chapter that would provide guidance for trade in deer and elk and their
products.
The United States will consider its position on this new standard
after it reviews a prepared draft.
In addition, the Code Commission anticipates establishing
guidelines for the following issues:
1. Guidelines on the judgment of equivalence: This represents a new
undertaking for OIE and is intended to provide guidance on making
equivalency determinations in the area of animal health. The United
States will consider its position on this issue once it reviews a
prepared draft.
2. Notification of animal diseases: Work in this area is intended
to provide improved guidance on procedures to follow for reporting
animal disease outbreaks and occurrences among OIE members. The United
States will consider its position on this matter after it reviews a
prepared draft.
3. Code appendices on embryos: Work in this area is intended to
ensure that all OIE Code chapters that address different animal
diseases include adequate guidance on export certification for trade in
embryos with respect to that particular disease. The United States will
consider its position on this matter after it reviews a prepared draft.
Other OIE Topics
Every year at the General Session, two technical items are
presented. At the May 2001 General Session, the following technical
items were presented:
1. The importance of emerging diseases in public and animal health
and trade. An expert in this area, including new zoonotic diseases,
provided a summary report on this topic. This report is expected to be
included in the report of the OIE's 2001 General Session.
2. The role of communication management in supporting veterinary
services. An expert on public information provided a summary report on
how different OIE member countries address their public information
needs with regard to informing the public about their animal health
activities. This report will also be published in the report of the
OIE's 2001 General Session. The two technical items for the May 2002
General Session have not yet been determined.
The information in this notice includes all the information
currently available to us on OIE standards currently under development
or consideration. Information on OIE standards is available on the OIE
web page at http://www.oie.int. Further, a formal agenda for the next
General Session will be available to member countries in February 2002,
and copies will be available to the public once the agenda is
published. For the most current information on meeting times, working
groups, and/or meeting agendas, including information on official U.S.
participation in OIE activities, and U.S. positions on standards being
considered, contact Dr. Michael David (see FOR FURTHER INFORMATION
CONTACT above). Those wishing to provide comments on any areas of work
under the OIE may do so at any time by responding to this notice (see
ADDRESSES above) or by providing comments through Dr. David.
IPPC Standard-Setting Activities
The IPPC is a multilateral convention adopted in 1952 for the
purpose of securing common and effective action to prevent the spread
and introduction of pests of plants and plant products and to promote
appropriate measures for their control. Under the IPPC, the
understanding of plant protection has been, and continues to be, broad,
encompassing the protection of both cultivated and noncultivated plants
from direct or indirect injury by plant pests. Activities addressed by
the IPPC include the development and establishment of international
plant health standards, the harmonization of phytosanitary activities
through emerging standards, the facilitation of the exchange of
official and scientific information among countries, and the furnishing
of technical assistance to developing countries that are signatories to
the IPPC.
The IPPC is placed under the authority of the FAO, and the members
of the Secretariat of the IPPC are appointed by the FAO. The IPPC is
implemented by national plant protection organizations in cooperation
with regional plant protection organizations, the Interim Commission on
Phytosanitary Measures (ICPM), and the Secretariat of the IPPC. The
United States plays a major role in all standard-setting activities
under the IPPC and has representation on FAO's highest governing body,
the FAO Conference.
The United States became a contracting party to the IPPC in 1972
and has been actively involved in furthering the work of the IPPC ever
since. The IPPC was amended in 1979, and the amended version entered
into force in 1991 after two-thirds of the
[[Page 43174]]
contracting countries accepted the amendment. More recently, in 1997,
contracting parties completed negotiations on further amendments that
were approved by the FAO Conference and submitted to the parties for
acceptance. This 1997 amendment updated phytosanitary concepts and
formalized the standard-setting structure within the IPPC. The 1997
amended version of the IPPC will enter into force once two-thirds of
the current contracting parties notify the Director General of FAO of
their acceptance of the amendment. At this date, 21 of the required 72
member countries have deposited their official letters of acceptance.
The U.S. Senate gave its advice and consent to acceptance of the newly
revised IPPC on October 18, 2000. The United States is in the process
of preparing and submitting to the FAO Director General its official
instrument of acceptance.
The IPPC has been, and continues to be, administered at the
national level by plant quarantine officials whose primary objective is
to safeguard plant resources from injurious pests.
In the United States, the national plant protection organization is
APHIS' Plant Protection and Quarantine (PPQ) program. The steps for
developing a standard under the revised IPPC are described below.
Step 1: Proposals for a new international standard for
phytosanitary measures (ISPM) or for the review or revision of an
existing ISPM are submitted to the Secretariat of the IPPC in the form
of a discussion paper accompanied by a topic or draft standard. Drafts
can be submitted by individual countries, but are more commonly
submitted by regional plant protection organizations (RPPO's).
Alternately, the Secretariat can propose a new standard or amendments
to existing standards.
Step 2: A summary of proposals is submitted by the Secretariat to
the ICPM. The ICPM identifies the topics and priorities for standard
setting from among the proposals submitted to the Secretariat and
others that may be raised by the ICPM.
Step 3: Specifications for the standards identified as priorities
by the ICPM are drafted by the Secretariat. The draft specifications
are submitted to the Standards Committee for approval/amendment and are
subsequently made available to members and RPPO's for comment (60
days). Comments are submitted in writing to the Secretariat. Taking
into account the comments, the Standards Committee finalizes the
specifications.
Step 4: The standard is drafted or revised in accordance with the
specifications by a working group designated by the Standards
Committee. The resulting draft standard is submitted to the Standards
Committee for review.
Step 5: Draft standards approved by the Standards Committee are
distributed to members by the Secretariat and RPPO's for consultation
(120 days). Comments are submitted in writing to the Secretariat. Where
appropriate, the Standards Committee may establish open-ended
discussion groups as forums for further comment. The Secretariat
summarizes the comments and submits them to the Standards Committee.
Step 6: Taking into account the comments, the Secretariat, in
cooperation with the Standards Committee, revises the draft standard.
The Standards Committee submits the final version to the ICPM for
adoption.
Step 7: The ISPM is established through formal adoption by the ICPM
according to Rule X of the Rules of Procedure of the ICPM.
Step 8: Review of the ISPM is completed by the specified date or
such other date as may be agreed upon by the ICPM.
Each member country is represented on the ICPM by a single
delegate. Although experts and advisers may accompany the delegate to
meetings of the ICPM, only the delegate (or an authorized alternate)
may represent each member country in considering a standard up for
approval. Parties involved in a vote by the ICPM are to make every
effort to reach agreement on all matters by consensus. Only after all
efforts to reach a consensus have been exhausted may a decision on a
standard be passed by a vote of two-thirds of delegates present and
voting.
Technical experts from the United States have participated directly
in working groups and indirectly as reviewers of all IPPC draft
standards. In addition, documents and positions developed by APHIS and
NAPPO have served as the bases for many of the standards adopted to
date. This notice describes each of the IPPC standards currently under
consideration or up for adoption. The full text of each standard will
be available on the APHIS Internet website at http://
www.aphis.usda.gov/ppq/standards. Interested individuals may review the
standards posted on this website and submit comments via the website.
The next ICPM meeting is scheduled for March 11-13, 2002. The
Deputy Administrator for APHIS' PPQ program is the U.S. delegate to the
ICPM. The Deputy Administrator intends to participate in the
proceedings and will discuss or comment on APHIS' position on any
standard up for adoption. The provisional agenda for the meeting is as
follows:
Provisional Agenda for the Fourth Interim Commission on
Phytosanitary Measures
1. Opening of the session.
2. Adoption of the agenda.
3. Report by the chairperson.
4. Report by the Secretariat.
5. Adoption of international standards (see section below entitled
``IPPC Standards Up for Adoption in 2002'' for details).
6. Items arising from the Third Session of the ICPM (see section
below entitled ``New Standard Setting Initiatives'' for details).
7. Work program for harmonization.
8. Status of the 1997 revised IPPC.
9. Other business.
10. Date and venue of the next meeting.
11. Adoption of the report.
IPPC Standards Up for Adoption in 2002
It is expected that the following standards will be sufficiently
developed to be considered by the ICPM for adoption at its March 2002
meeting. The United States, represented by APHIS' Deputy Administrator
for PPQ, will participate in the consideration of these standards. The
U.S. position on each of these issues will be developed prior to the
ICPM session and will be based on APHIS' analysis, information from
other U.S. Government agencies, and relevant scientific information
from interested stakeholders. The standards that are most likely to be
considered for adoption include:
1. Guidelines for pest listing: The IPPC requires contracting
parties to establish and update lists of regulated pests for
phytosanitary certification purposes. Guidelines were developed for
meeting these obligations at a working group meeting in January 2000.
These draft guidelines describe lists of regulated pests, the purpose
of the guidelines, and their relationship to phytosanitary
certification procedures. The United States intends to support adoption
of this draft standard assuming it is ready for such consideration.
2. Guidelines for pest reporting: Under the IPPC, members have an
obligation to report pest outbreaks or incidents that may be of
potential danger to other members. This standard will provide a common
format for such reporting between members. The United States intends to
support adoption of
[[Page 43175]]
this draft standard assuming it is ready for such consideration.
3. General considerations and specific requirements for regulated
non-quarantine pests: The 1997 revised IPPC broadened the scope of
regulated pests to include ``regulated non-quarantine pests.'' These
are defined as a non-quarantine pests associated with propagative
materials and whose presence in such plants affects the intended use of
those plants with an economically unacceptable impact and are therefore
regulated by the national plant protection organization. This standard
describes the concept of regulated non-quarantine pests and identifies
their characteristics. It also describes the application of the concept
in practice and relevant elements for regulatory systems. This general
standard will be followed at a later time by the development of a
related standard that will provide guidance for conducting pest risk
analyses specific to regulated non-quarantine pests (see item 7 under
``New Standard-Setting Initiatives''). The United States intends to
support adoption of this draft standard assuming it is ready for such
consideration.
4. Systems approaches for risk management: Given the eventual loss
of methyl bromide as a quarantine tool, many countries are relying
increasingly on new approaches for reducing pest risks and meeting
foreign import requirements. Systems approaches, or the use of multiple
pest risk mitigation measures, have emerged as an increasingly popular
way to certify commodities for export. This standard is intended to
harmonize the approach used by countries in establishing systems
approaches for export purposes. The United States intends to support
adoption of this draft standard assuming it is ready for such
consideration.
At this time, it appears likely that only the above standards will
be presented for adoption at the next ICPM meeting in April 2002. The
United States intends to support adoption of these standards at the
April 2002 ICPM meeting.
New Standard-Setting Initiatives
A number of expert working group meetings or other technical
consultations will take place during 2001 and early 2002 on the topics
listed below. These standard-setting initiatives are not expected to be
completed prior to March 2002 and, therefore, will not be ready for
adoption at the 2002 ICPM session. Nonetheless, APHIS intends to
participate actively and fully in each of these working groups. The
U.S. position on each of the topics to be addressed by these various
working groups will be developed prior to these working group meetings
and will be based on APHIS' technical analysis, information from other
U.S. Government agencies, and relevant scientific information from
interested stakeholders.
1. Environmental impact of quarantine pests, including invasive
species: The ICPM agreed to establish a technical expert group to
further develop an IPPC standard for evaluating the environmental
impacts of quarantine pests, including quarantine pests that are
invasive. A technical expert group was scheduled to meet on this issue
August 6-10, 2001. The first effort to solicit input from the public
took place on March 8, 2001, when APHIS held a public meeting on
genetically modified organisms (GMO's) and invasive species. The
transcript of this public meeting is available on the Internet at
http://www.aphis.usda.gov/ppd/rad/webrepor.html. We plan to publish a
second request for comment from the public in the Federal Register in
July 2001 before this particular standard is discussed at the August
2001 meeting.
2. Living modified organisms (LMOs): The ICPM agreed on the need to
develop a standard to address the plant pest risk of LMOs. The first
preparatory step, however, is to develop the specifications for an LMO
standard (i.e., elements and parameters to guide the development of a
particular standard). An open-ended expert working group will meet in
September 2001. This expert working group is charged to develop a
detailed standard specification that identifies the plant pest risks
associated with LMOs or products of modern biotechnology; identifies
elements relevant to the assessment of these plant pest risks;
considers existing international regulatory frameworks and guidelines;
identifies areas within pest risk assessment (PRA) standards and other
ISPM's that are relevant to the phytosanitary aspects of LMOs that are
products of modern biotechnology; and identifies the plant pest risks
associated with LMOs that are products of modern biotechnology that are
not adequately addressed by existing ISPM's. The target date for
completion of the LMO standard is 2004. The first effort to solicit
input from the public took place on March 8, 2001, when APHIS held a
public meeting on GMO's and invasive species. The transcript of this
public meeting is available on the Internet at http://
www.aphis.usda.gov/ppd/rad/webrepor.html. We plan to publish a second
request for comment from the public in July 2001 before this particular
standard is discussed at the September 2001 meeting.
3. Strategic planning and technical assistance: A working group on
strategic planning and technical assistance will meet in October 2001
to update the ICPM's strategic plan, including its technical assistance
program. In particular, the strategic planning group will seek to
further develop specific procedures for identifying topics and
establishing setting standard-setting priorities; develop a program for
the promotion of technical assistance on phytosanitary issues;
determine priorities for the IPPC Secretariat's technical assistance
activities; and support the development of guidance for countries to
use in the evaluation of national regulatory systems.
4. RPPO technical consultation: The establishment of guidelines for
the recognition of RPPO's is a function of the ICPM. The task of
preparing draft guidelines on this subject was completed during a RPPO
technical consultation held in September 2000. During the RPPO
consultation scheduled for 2001, procedures that describe how the
guidelines are to be implemented will be developed for consideration by
the next session of the ICPM.
5. Guidelines on the use of nonmanufactured wood packing materials:
This standard will describe phytosanitary measures to reduce the risk
of introduction and spread of quarantine pests associated with
nonmanufactured wood packing materials used for the transport of
commodities in international trade. The Standards Committee will
continue work on this draft standard. It is not expected to be
completed and ready for ICPM adoption until 2003.
6. Guidelines for surveillance for specific pests--citrus canker:
Plant health officials may obtain information on pests of concern in
specific sites in an area over a defined period of time through
specific surveys. The collected information may be used to determine
the presence or distribution of pests in an area, or on a host or
commodity, or their absence from an area (in order to establish and
maintain pest-free areas). This specific surveillance standard will
describe the components of survey and monitoring systems for the
purpose of detecting citrus canker and generating the necessary data
for use in pest risk analyses, the establishment of pest free areas
and, where appropriate, the preparation of pest lists.
7. Pest risk analysis for regulated non-quarantine pests: Certain
pests that are not quarantine pests may be subject to phytosanitary
regulations and
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procedures because their presence above a specific level results in
economically unacceptable impacts associated with the intended use of
the plants. Under the IPPC, such pests are referred to as regulated
non-quarantine pests. Under the IPPC, phytosanitary regulations and
procedures covering regulated non-quarantine pests should be
technically justified. The classification of a pest as a regulated non-
quarantine pest and any restrictions placed on the importion of the
plant species with which it is associated must be justified by pest
risk analysis. This standard will provide guidance for conducting an
appropriate pest risk assessment necessary to demonstrate that
importation of a particular plant for propagation is a pathway that may
result in an economically unacceptable impact and to guide subsequent
risk management decisions.
8. Irradiation as a quarantine treatment: This initiative will
consider the development of standardized guidance for evaluating,
adopting, and applying irradiation as a phytosanitary treatment. The
objective is to promote consistency by providing harmonized guidelines
concerning the technical and operational aspects of employing
irradiation as a treatment for plant pests. The International Atomic
Energy Agency (IAEA) based in Vienna, Austria, has offered both
technical and financial support for the development of an irradiation
standard.
For more detailed information on the above topics, which will be
addressed by various working groups established by the ICPM, contact
Mr. Narcy Klag (see FOR FURTHER INFORMATION CONTACT above).
Also, APHIS posts draft standards on its website (http://
www.aphis.usda.gov/ppq/standards) as they become available to us. The
website also provides information on when comments on standards are
due. Additional information on IPPC standards is available on the FAO's
website at http://www.ippc.int. For the most current information on
official U.S. participation in IPPC activities, including U.S.
positions on standards being considered, contact Mr. Narcy Klag (see
FOR FURTHER INFORMATION CONTACT above). Those wishing to provide
comments on any of the areas of work being undertaken by the IPPC may
do so at any time by responding to this notice (see ADDRESSES above) or
by providing comments through Mr. Klag.
NAPPO Standard-Setting Activities
NAPPO, a regional plant protection organization created in 1976
under the IPPC, coordinates the efforts among Canada, the United
States, and Mexico to protect their plant resources from the entry,
establishment, and spread of harmful plant pests, while facilitating
intra- and inter-regional trade.
NAPPO conducts its business through panels and annual meetings held
among the three member countries. The NAPPO Executive Committee charges
individual panels with the responsibility for drawing up proposals for
NAPPO positions, policies, and standards. These panels are made up of
representatives from each member country who have scientific expertise
related to the policy or standard being considered.
Proposals drawn up by the individual panels are circulated for
review to government and industry officials in Canada, Mexico, and the
United States, who may suggest revisions. In the United States, draft
standards are circulated to industry, States, and various government
agencies for consideration and comment. The draft standards are posted
on the Internet at http://www.aphis.usda.gov/ppq/standards. Interested
persons may submit comments via this website. Once revisions are made,
the proposal is sent to the NAPPO working group and the NAPPO standards
panel for technical reviews and then to the Executive Committee for
final approval, which is granted by consensus.
The annual NAPPO meeting is scheduled for October 16-18, 2001, in
Banff, Alberta, Canada. The Executive Committee meeting will take place
on October 14, 2001, and a special session will be held on October 15,
2001, where industry groups can bring issues to the attention of the
Executive Committee. The Deputy Administrator for APHIS' PPQ program is
the U.S. member of the Executive Committee. The Deputy Administrator
intends to participate in the proceedings and will discuss or comment
on APHIS' position on any standard up for adoption in the event that
there is no consensus on whether to adopt that standard.
Work Plan for 2001/2002--NAPPO Panel Activities
The work plan for the year was established after the October 2000
Annual Meeting in San Diego, CA. The Deputy Administrator for PPQ
participated in establishing this NAPPO work plan (see panel
assignments below).
Below is a summary of current panel assignments as they relate to
the ongoing development of NAPPO standards. USDA/APHIS intends to
participate actively and fully in the work of each of these panels. The
U.S. position on each topic will be guided and informed by the best
scientific information available on each of these topics. Information
regarding the following NAPPO panel topics, assignments, and
activities, and updates on meeting times and locations, may be obtained
from the NAPPO home page at http://www.nappo.org or by contacting Mr.
Narcy Klag (see FOR FURTHER INFORMATION CONTACT above).
Accreditation Panel (Laboratory Accreditation Standard): This NAPPO
panel will undertake the following in support of the ``Accreditation of
Laboratories for Phytosanitary Testing'' standard: (1) Develop a
process for the evaluation and acceptance of equivalent diagnostic
tests used by NAPPO countries; and (2) collaborate with other NAPPO
panels as required regarding the ongoing maintenance of the inventory
of NAPPO-approved diagnostic tests. The United States will consider its
position on this standard after it reviews a prepared draft.
Accreditation Panel (Inspector Accreditation): This NAPPO panel
will work towards implementing the conditions of the ``Accreditation of
Individuals to Sign Federal Phytosanitary Certificates'' standard. A
review of the U.S. system was conducted in June 2001; reviews of other
countries' systems will follow. A written report will be given to the
Executive Committee at its meeting on October 14, 2001.
Biological Control Panel: This panel will develop a protocol for
post-release monitoring to be incorporated as part of the existing
standards on biological control (``Guidelines for Petition for Import
and Release of Nonnative Entomophagous Agents for the Biological
Control of Pests,'' and ``Guidelines for Petition for Import and
Release of Nonnative Phytophagous Agents for the Biological Control of
Pests''). The United States will consider its position on this protocol
after it reviews a prepared draft.
Biotechnology Panel: This panel will develop a NAPPO standard for
the review of products of biotechnology that focuses on the assessment
of the potential to present a plant pest risk. It will finalize modules
1, 2, and 3 of the standard regarding the importation of transgenic
plants for release into contained facilities, for confined field
release, and for unconfined field release, respectively. The panel will
begin development of module 4 regarding importation of transgenic
material for uses other than planting.
The panel will also collaborate with the NAPPO Pest Risk Analysis
Panel to contribute to the development of
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international standards on the plant pest risks of LMOs/products of
modern biotechnology and on the environmental risks associated with
plant pests. The United States will consider its position on this
standard after it reviews a prepared draft.
Citrus Panel: This panel will continue the development of a NAPPO
citrus standard entitled, ``Guidelines for the Importation into and
Movement of Citrus Propagative Material within NAPPO Countries with
Respect to Viruses and Virus-like Pests, Viroids, Phytoplasms,
Bacteria, and Fungi.'' The United States will consider its position on
this standard after it reviews a prepared draft.
Forestry Panel: This panel will continue to share information
received from consultations on the NAPPO nonmanufactured wood packing
material standard, participate in the development of the international
standard on nonmanufactured wood packing material, and cooperate with
the Insect and Disease Study Group of the North American Forestry
Commission to identify quarantine pests and treatment options for
nonmanufactured wood packing material and research priorities in
support of regional and international standards for nonmanufactured
wood packing material. The United States will consider its position on
any standard developed by this panel after it reviews a prepared draft.
Fruit Panel: This panel will complete the standard on
``Verification and Maintenance of Fruit Fly-Free Areas.'' The United
States will consider its position on this standard after it reviews a
prepared draft.
Fruit Tree Panel: This panel will develop a list of standardized
diagnostic tests to be used when certifying fruit tree nursery stock.
The United States will consider its position on the list of tests after
it reviews a prepared draft.
Grain Panel: This panel will develop a list of standardized
diagnostic tests to be used when certifying grain shipments and will
complete guidelines for the establishment, verification, and
maintenance of free areas for Karnal bunt. The United States will
consider its position on the list of tests and the guidelines after it
reviews the prepared drafts.
Grapevine Panel: This panel will develop a list of standardized
diagnostic tests to be used when certifying grapevine shipments. The
United States will consider its position on the list of tests after it
reviews a prepared draft.
Pest Risk Analysis Panel: This panel will collaborate with the
Potato Panel in the development of a PRA to support implementation of
the NAPPO standard on ``Requirements for the Importation of Potatoes
into a NAPPO Member Country.'' Also, it will collaborate with the NAPPO
Biotechnology Panel to contribute to the development of international
standards on the plant pest risks of LMOs/products of modern
biotechnology and on the environmental risks associated with plant
pests. The United States will consider its position on this standard
after it reviews a prepared draft.
Potato Panel: This panel will develop a standard that provides
detailed criteria that would define appropriate conditions for
minituber production and list the standardized diagnostic tests to be
used when certifying potato shipments. The United States will consider
its position on this standard after it reviews a prepared draft.
Seeds Panel: This panel will prepare a proposal to the IPPC to
endorse the seed-testing methods of the International Seed Testing
Association, as well as develop a list of standardized diagnostic tests
to be used when certifying seed shipments. The United States will
consider its position on the proposal and the list of tests after it
reviews the prepared drafts.
Standards Panel: This panel is responsible for providing updates on
standards in the NAPPO newsletter; coordinating the review of new and
amended NAPPO standards and ensuring that comments received during the
country consultation phase are incorporated as appropriate; organizing
conference calls and preparing NAPPO discussion documents for possible
use at the IPPC; promoting implementation of finalized NAPPO guidelines
and standards; and developing a NAPPO process for implementing the
recently adopted IPPC standard for the ``Notification of Interceptions
and Non-Compliance'' within the NAPPO region.
The PPQ Deputy Administrator, as the official U.S. delegate to
NAPPO, intends to participate in the adoption of those regional plant
health standards, including the work described above, once they are
completed and ready for such consideration.
The information in this notice includes all the information
available to us on NAPPO standards currently under development or
consideration. For updates on meeting times and for information on the
working panels that becomes available following publication of this
notice, check the NAPPO web page at http://www.nappo.org or contact Mr.
Narcy Klag (see FOR FURTHER INFORMATION CONTACT above). Information on
official U.S. participation in NAPPO activities, including U.S.
positions on standards being considered, may also be obtained from Mr.
Klag.
Those wishing to provide comments on any of the topics being
addressed by any of the NAPPO panels may do so at any time by
responding to this notice (see ADDRESSES above) or by transmitting
comments through Mr. Klag.
Done in Washington, DC, this 9th day of August 2001.
Craig A. Reed,
Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 01-20692 Filed 8-16-01; 8:45 am]
BILLING CODE 3410-34-U