International Sanitary and Phytosanitary Standard-Setting Activities
Federal Register: July 28, 2008 (Volume 73, Number 145)
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
Docket No. APHIS-2008-0063
International Sanitary and Phytosanitary Standard-Setting
AGENCY: Animal and Plant Health Inspection Service, USDA.
ACTION: Notice and request for comments.
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 the international standard- setting activities of the World Organization for Animal Health, 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: You may submit comments by either of the following methods:
Federal eRulemaking Portal: Go to http:// www.regulations.gov/fdmspublic/component/ main?main=DocketDetail&d=APHIS-2008-0063 to submit or view comments and to view supporting and related materials available electronically.
Postal Mail/Commercial Delivery: Please send two copies of your comment to Docket No. APHIS-2008-0063, Regulatory Analysis and
Development, PPD, APHIS, Station 3A-03.8, 4700 River Road Unit 118,
Riverdale, MD 20737-1238. Please state that your comment refers to
Docket No. APHIS-2008-0063.
Reading Room: 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.
Other Information: Additional information about APHIS and its programs is available on the Internet at http://www.aphis.usda.gov.
FOR FURTHER INFORMATION CONTACT: For general information on the topics covered in this notice, contact Mr. John Greifer, Associate Deputy
Administrator for SPS Management, 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 World Organization for Animal Health, contact Dr. Michael David,
Director, Sanitary International Standards Team, National Center for
Import and Export, VS, APHIS, 4700 River Road Unit 33, Riverdale, MD 20737-1231; (301) 734-5324.
For specific information regarding the standard-setting activities of the International Plant Protection Convention or the North American
Plant Protection Organization, contact Ms. Julie E. Aliaga, Program
Director, International Phytosanitary Standards, PPQ, APHIS, 4700 River
Road, Riverdale, MD 20737-1236; (301) 734-0763.
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 Agreements 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 World Organization for Animal Health (OIE, formerly known as the Office International des Epizooties) 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 informing the public of the SPS standard-setting activities of Codex, OIE, IPPC, and NAPPO. The United States Department of
Agriculture's (USDA's) Food Safety and Inspection Service (FSIS) informs the public of Codex standard-setting activities, and USDA's
Animal and Plant Health Inspection Service (APHIS) informs the public of OIE, IPPC, and NAPPO standard-setting activities.
FSIS publishes 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 an annual notice of OIE, IPPC, and NAPPO activities related to international standards for plant and animal health and representing the 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 organizations. 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 172 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 disease events, 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 science-based standards govern international trade in animals and animal products. The OIE aims to achieve these 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. Various OIE commissions and working groups undertake the development and preparation of draft standards, which are then circulated to Member countries for consultation (review and comment).
Draft standards are revised accordingly and are then presented to the
OIE International Committee (all the Member countries) during the
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 May 24-29, 2009, in
Paris, France. Currently, the Deputy Administrator of APHIS Veterinary
Services is the official U.S. Delegate to the OIE. The Deputy
Administrator of APHIS intends to participate in the proceedings and will discuss or comment on APHIS' position on any standard up for adoption. Information about OIE draft Terrestrial and Aquatic Animal
Health Code chapters may be found on the Internet at http:// www.aphis.usda.gov/import_export/animals/oie/ or by contacting Dr.
Michael David (see FOR FURTHER INFORMATION CONTACT above).
OIE Terrestrial Animal Health Code Chapters and Appendices Adopted by the May 2008 General Session
Note: Proposed appendices and chapters not yet assigned by number have been designated an ``x'' as a temporary placeholder by the OIE.) 1. Chapter 1.1.1, General Definitions
Various definitions were modified and updated, including the definitions for ``animal welfare,'' ``infection,'' ``herd,'' ``flock,''
``monitoring,'' and ``surveillance.'' 2. Chapter 1.2.1, General Obligations
The text in this chapter was modified to provide additional clarity regarding its content. 3. Chapter 1.3.5, Zoning and Compartmentalization
Minor changes were made to this chapter. 4. Chapter 2.2.10, Foot and Mouth Disease
Guidelines for quicker recovery of status after an outbreak, and the concept of ``containment zone'' were amended this year. In addition, a minor clarification to the definition of ``buffer zone'' was made. 5. Chapter 2.3.3, Bovine Tuberculosis
This chapter has undergone a revision to reflect current understanding of the disease. 6. Chapter 2.3.13, Bovine Spongiform Encephalopathy
This chapter received further modifications this year. In particular, restrictions on gelatin manufactured from certain bones
(vertebrae and skulls) sourced from countries classified as either
``controlled'' or ``undetermined'' risk for BSE were increased. 7. Appendix 3.8.5, Factors To Consider in Conducting the Bovine
Spongiform Encephalopathy Risk Assessment Recommended in Chapter 2.3.13
This appendix was revised by removing any reference to other transmissible spongiform encephalopathies (TSEs). 8. Section 2.5, Equine Diseases
The following equine Code chapters received further updates:
Chapter 2.5.5, Equine influenza; Chapter 2.5.7, Equine rhinopneumonitis; Chapter 2.5.10, Equine viral arteritis; and Chapter 2.5.14, African horse sickness. 9. Chapter 2.7.12, Avian Influenza
No significant changes were made to the content of this chapter; however, the Code Commission has asked the Scientific Commission to review the scientific literature to improve the current provisions for the inactivation of avian influenza virus in poultry meat and eggs and in poultry products intended for animal feeding or for agricultural use. 10. Chapter 2.7.13, Newcastle Disease
The chapter on Newcastle disease is modeled after the chapter on avian influenza. The definition of Newcastle
disease was clarified for Member countries regarding what is reportable. 11. Appendix 3.7.2, Guidelines for the Transport of Animals by Sea;
Appendix 3.7.3, Guidelines for the Transport of Animals by Land;
Appendix 3.7.5, Guidelines for the Slaughter of Animals; and Appendix 3.7.6, Guidelines for the Killing of Animals for Disease Control
As in previous years, these guidelines were slightly updated. 12. Appendix x.x.x, Guidelines on Dog Population Control
The draft guidelines on stray dog control have undergone a second revision and are likely to undergo further revisions in the coming years. 13. Appendix x.x.x, Animal Identification and Traceability
This draft appendix has been further modified to provide Member countries with some general guidelines to consider when designing and implementing an animal identification system.
OIE Terrestrial Animal Health Code Chapters and Appendices for Future
Existing Terrestrial Animal Health Code chapters that may be revised and new chapters that may be drafted in preparation for the next General Session in 2009 include the following: 1. Chapter 2.2.x, West Nile Fever
Due to the number of comments received this year, the Code
Commission will address changes to this chapter for the next session in
May 2009. 2. Chapter 2.3.1, Bovine Brucellosis 3. Chapter 2.3.15, Contagious Bovine Pleuropneumonia 4. Chapter 2.4.8, Scrapie 5. Chapter 2.10.2, Salmonella Enteritidis and Salmonella Typhimurium in
Poultry 6. Appendix 3.4.1, Hygiene and Disease Security Guidelines in Poultry
Breeding Flocks and Hatcheries 7. Appendix 3.10.2, Guidelines on the Detection, Control, and
Prevention of Salmonella Enteritidis and Salmonella Typhimurium in
Poultry Producing Eggs for Human Consumption 8. Appendix x.x.x, Guidelines for the Control of Hazards of Animal
Health and Public Health Importance in Animal Feed 9. Appendix x.x.x, Guidelines for the Harvesting and Culling of
Wildlife 10. Appendix x.x.x, Guidelines for Laboratory Animal Welfare
OIE Aquatic Animal Health Code Chapters and Appendices up for Adoption
Aquatic Animal Health Code chapters and appendices that have been revised or which are new for adoption at the 2009 General Session include:
Chapter 1.1.1, Definitions; Chapter 1.2.3, Diseases listed by the
OIE; Chapter 1.3.1, General obligations; Chapter 2.2.5, Infection with
Mikrocytos mackini; Chapter 2.3.9, Infectious myonecrosis; Chapter 2.3.11, White Tail disease; Chapter 2.4.1, Infection with
Batrachochytrium dendrobatidis; Chapter 2.4.2, Infection with ranavirus; Chapter x.x.x, Guidelines for aquatic animal health surveillance; and Chapter x.x.x., Guidelines for the control of aquatic animal health hazards in aquatic animal feeds.
OIE Aquatic Animal Commission Future Work Program
During the next few years, the OIE Aquatic Animal Commission may address the following issues or establish ad hoc groups of experts to update or develop standards for the following issues: 1. Guidelines on the handling and disposal of carcasses and wastes of aquatic animals. 2. Chapter 2.3.7, Crayfish plague.
The OIE Code chapters are drafted (or revised) by either the
Terrestrial or Aquatic Animal Health Standards Commission or by ad hoc groups composed of technical experts nominated by the Director General of the OIE by virtue of their subject-area expertise. Once a new chapter is drafted or an existing one is revised, the chapter is distributed to Member countries for review and comment. The OIE attempts to provide proposed chapters by late October to allow Member countries sufficient time for comment. Comments are due by late January of the following year. The draft standard is revised by the OIE Code
Commission on the basis of relevant scientific comments received from
The United States (i.e., USDA/APHIS) intends to review, and where appropriate, comment on all draft chapters and revisions once it receives them from the OIE. USDA/APHIS intends to distribute these drafts to the U.S. livestock and aquaculture industries, veterinary experts in various U.S. academic institutions, other State and Federal agencies, and other interested persons for review and comment.
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 pertinent OIE Code 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 and comment on proposed standards, and make decisions regarding the adoption of those standards, strictly on their scientific merits.
Other OIE Topics
Every year at the General Session, at least one technical item is presented. For the May 2009 General Session, the following technical item will be presented: 1. Impact of climate change and environmental changes on emerging and re-emerging animal diseases and animal production.
The information in this notice includes all the information available to us on OIE standards currently under development or consideration. Information on OIE standards is available on the
Internet at http://www.oie.int. Further, a formal agenda for the next
General Session should be available to Member countries by March 2009, 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. Michael
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 under the authority of the Food and Agriculture
Organization (FAO), and the members of the Secretariat of the IPPC are appointed by the FAO. The IPPC is implemented by national plant protection organizations (NPPOs) in cooperation with regional plant protection organizations (RPPOs); the Commission on Phytosanitary
Measures ((CPM), formerly referred to as the International 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 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 entered into force after two-thirds of the contracting parties notified the Director General of FAO of their acceptance of the amendment in
October 2005. The U.S. Senate gave its advice and consent to acceptance of the newly revised IPPC on October 18, 2000. The President submitted the official letter of acceptance to the FAO Director General on
October 4, 2001.
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 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 a standardized format on a 2-year cycle. Alternatively, the Secretariat can propose a new standard or amendments to existing standards.
Step 2: After review by the Standards Committee and the Strategic
Planning and Technical Assistance Working Group, a summary of proposals is submitted by the Secretariat to the CPM. The CPM identifies the topics and priorities for standard setting from among the proposals submitted to the Secretariat and others that may be raised by the CPM.
Step 3: Specifications for the standards identified as priorities by the CPM are drafted by the Standards Committee. The draft specifications are subsequently made available to members and RPPOs 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 RPPOs for consultation
(100 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 CPM for adoption.
Step 7: The ISPM is established through formal adoption by the CPM according to Rule X of the Rules of Procedure of the CPM.
Step 8: Review of the ISPM is completed by the specified date or such other date as may be agreed upon by the CPM.
Each member country is represented on the CPM by a single delegate.
Although experts and advisors may accompany the delegate to meetings of the CPM, 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 CPM 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. The United States also has a representative on the Standards
Committee. In addition, documents and positions developed by APHIS and
NAPPO have been sources of significant input 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 Internet at http:// www.aphis.usda.gov/import_export/plants/plant_exports/draft_ standards_4_ comment.shtml. Interested individuals may review the standards posted on this Web site and submit comments via the Web site.
The next CPM meeting is scheduled for March 30-April 3, 2009, at
FAO Headquarters in Rome, Italy. The Deputy Administrator for APHIS'
PPQ program is the U.S. delegate to the CPM. The Deputy Administrator intends to participate in the proceedings and will discuss or comment on APHIS' position on any standards up for adoption. The agenda for the
Fourth Session of the Commission of Phytosanitary Measures is as follows: 1. Opening of the session 2. Adoption of the agenda 3. Election of the Rapporteur 4. Report by the CPM chairperson 5. Report by the Secretariat 6. Report of the technical consultation among RPPOs 7. Report of observer organizations 8. Goal 1: A robust international standard-setting and implementation programme 8.1 Report by the chairperson of the
Standards Committee 8.2 Adoption of international standards--under the regular process 8.3 Adoption of international standards--under the special-track process 8.4 IPPC standard-setting work programme (with proposed adjustments) 9. Goal 2: Information exchange systems appropriate to meet IPPC obligations 9.1 Proposed work programme for 2009 10. Goal 3: Effective dispute settlement systems 10.1 Report of the chairperson of the Subsidiary Body on Dispute
Settlement 11. Goal 4: Improved phytosanitary capacity of members 12. Goal 5: Sustainable implementation of the IPPC 12.1 Report of the third meeting of the Strategic Planning and
Technical Assistance (SPTA) group 12.2 IPPC/CPM activities 12.2.1 State of membership to the IPPC 12.2.2 Acceptance of documents in electronic format 12.3 Update to the Business Plan 2008-2011 12.4 Financial report and budget 12.4.1 Financial report 2008 12.4.2 Financial report 2008 for the Trust Fund for the IPPC 12.4.3 CPM Operational Plan for 2009 12.4.4 Budget 2009 for the Trust Fund for the IPPC 12.5 Proposal for the adoption of CPM recommendations 13. Goal 6: International promotion of the IPPC and cooperation with relevant regional and international organizations 13.1 Report on the international promotion of the IPPC and cooperation with relevant regional and international organizations 14. Goal 7: Review of the status of plant protection in the world 15. Election of the Bureau 16. Membership of CPM subsidiary bodies 17. Calendar 18. Other business 19. Date and venue of the next meeting 20. Adoption of the report
IPPC Standards Adopted at the CPM-3 Session in 2008 1. Establishment of Areas of Low Pest Prevalence for Fruit Flies
This standard provides guidelines for the establishment and maintenance of areas of low pest prevalence for fruit flies of economic importance (including places and sites of production of low pest prevalence) for use as a risk mitigation measure to facilitate trade of fruits and vegetables. The decision to create a fruit fly area of low pest prevalence (FF-ALPP) for export of a particular host of fruit fly is closely linked to trade opportunities and to economic and operational feasibility. 2. Sampling of Consignments
This standard provides guidance to NPPOs in selecting appropriate sampling methodologies for inspection or testing of consignments to verify compliance with phytosanitary requirements. The standard provides a statistical basis for inspection of consignments of regulated articles moving in trade. 3. Amendments to ISPM No. 5 (Glossary of Phytosanitary Terms)
The following term and definition has been adopted to the
Glossary of phytosanitary terms in ISPM No. 5:
Bark: The layer of a woody trunk, branch or root outside the cambium.
The following terms and definitions have been revised in the
Bark-free wood: Wood from which all bark, except ingrown bark around knots and bark pockets between rings of annual growth, has been removed.
Debarked wood: Wood that has been subjected to any process that results in the removal of bark (debarked wood is not necessarily bark-free wood).
The following terms have been deleted from the Glossary:
Biological pesticide (biopesticide)
Classical biological control
Establishment (of a biological control agent)
Import Permit (of a biological control agent)
Introduction (of a biological agent)
Specificity 4. IPPC ISPM Recommendation No. 1: National Strategies for Replacing or
Reducing the Use of Methyl Bromide as a Phytosanitary Measure
IPPC Recommendation No. 1 provides guidance to NPPOs on the replacement of or reduction in the use of methyl bromide (MB) as a phytosanitary measure in order to reduce emissions of MB. With the overall aim of reducing release of MB into the atmosphere, NPPOs may consider methods of reducing the quantities of MB used, reducing MB emissions by physical means, and promoting and implementing phytosanitary measures that are economically and technically feasible as viable alternatives to the use of MB. This IPPC Recommendation also provides guidance on recording the use of MB and encourages NPPOs to share data with the country's National Ozone Unit (the national body responsible for the implementation of the Montreal Protocol).
IPPC Standards Up for Adoption in 2009
It is expected that the following standards will be sufficiently developed to be considered by the CPM for adoption at its 2009 meeting.
The United States, represented by APHIS' Deputy Administrator for PPQ, will participate in consideration of these standards. The U.S. position on each of these issues will be developed prior to the CPM session and will be based on APHIS' analysis, information from other U.S.
Government agencies, and relevant scientific information from interested stakeholders. 1. Structure and Operation of Post-Entry Quarantine Facilities
This standard describes general guidelines for the design and operation of post-entry quarantine (PEQ) facilities for holding consignments of plants in containment. Four levels of containment are specified. For all PEQ containment levels, an operating procedures manual should show how the PEQ facility meets the containment requirements. 2. Pest-Free Potato Micropropagative Material and Minitubers for
This standard will provide guidance on the production, maintenance, and certification of pest-free potato (Solanum spp.) micropropagative material and minitubers intended to be moved in international trade.
This standard does not apply to movement of field-grown seed potatoes intended for consumption or processing. 3. Categorization of Commodities According to Their Phytosanitary Risk
This standard will provide guidance for contracting parties on how to categorize commodities according to their phytosanitary risk when considering import requirements. This categorization could be useful in identifying whether further analysis is required.
The first stage of categorization is based on whether the commodity has been processed and, if so, the method and degree of processing to which the commodity has been subjected before
export. A second stage of categorization of commodities is based on their intended use after import.
Contaminating pests or storage pests that may become associated with the commodity after processing are not considered in this standard. 4. Regulating Wood Packaging Material in International Trade: Revision of ISPM No. 15
This standard describes phytosanitary measures that reduce the risk of introduction and/or spread of quarantine pests associated with the movement in international trade of wood packaging material made from raw wood. Wood packaging material covered by this standard includes dunnage but excludes wood packaging made from wood processed in such a way that it is free from pests.
Measures described in this standard are not intended to provide ongoing protection from contaminating pests or other organisms. 5. Amendments to ISPM No. 5 (Glossary of Phytosanitary Terms):
The following terms and definitions will be proposed for addition to the Glossary of phytosanitary terms in ISPM No. 5:
Incidence (of a pest): Proportion or number of units in a sample, consignment, field or other defined population that is affected by a pest.
Tolerance level (of a pest): Incidence of a pest that is a threshold for action to control that pest or to prevent its spread or introduction.
Phytosanitary security (of a consignment): Maintenance of the integrity of a consignment and prevention of its infestation and contamination by regulated pests through the application of appropriate phytosanitary measures.
Corrective action plan (in an area): Documented plan of phytosanitary actions to be implemented if a pest is detected or a specified pest level is exceeded in an area officially delimited for phytosanitary purposes.
The following terms will be proposed for revision:
Compliance procedure (for a consignment): Official procedure used to verify that a consignment complies with phytosanitary import requirements or phytosanitary measures related to transit.
Intended use: Declared purpose for which plants, plant products, or other articles are imported, produced, or used.
Reference specimen: Specimen (which may be a culture) from a population of a specific organism conserved in an accessible collection, for the purpose of identification, verification or comparison. 6. Terminology of the Convention of Biological Diversity in Relation to the Glossary of Phytosanitary Terms: Draft Supplement to ISPM No. 5
(Glossary of Phytosanitary Terms)
In order to address initiatives within the IPPC regarding the protection of the environment and of biological diversity in relation to the introduction and spread of non-indigenous species, relevant terminology concerning the environment and biological diversity for use in ISPMs is needed. The Convention on Biological Diversity (CBD) has proposed a number of such terms and definitions in the framework of its
``guiding principles for the prevention, introduction and mitigation of impacts of alien species that threaten ecosystems, habitats or species.'' Attempts to incorporate these terms into IPPC language for the Glossary have proven unsuccessful due to conceptual differences, therefore the CBD's terms are explained in this supplement. 7. Fruit Fly Trapping: Annex 1 to ISPM No. 26 (Establishment of Pest
Free Areas for Fruit Flies (Tephritidae))
This annex provides detailed information for trapping surveys under different scenarios of pest population and control situations for different fruit fly species (Tephritidae) of economic importance.
Different trapping systems and procedures should be used depending on the fruit fly status of the target area, which can be either an infested area, an area of low pest prevalence (ALPP), or a pest-free area (PFA). The information in this annex can therefore be applied to other ISPMs relating to fruit flies. The annex describes the most widely used trapping systems and procedures, although others are available that may obtain equivalent results for fruit fly surveys.
New Standard-Setting Initiatives, Including Those in Development
A number of expert working group meetings or other technical consultations will take place during 2008 and 2009 on the topics listed below. These standard-setting initiatives are under development and may be considered for future adoption. 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. Preclearance for Regulated Articles
This standard will provide guidance on the justification, establishment, reviewing, phasing out, and terminating of pre-clearance arrangements and offer a model framework for pre-clearance programs
(where justified), including criteria for terminating pre-clearance arrangements in favor of other phytosanitary measures. 2. Systems Approach(es) for Pest Risk Management of Fruit Flies
This standard will provide guidelines for the establishment and use of systems approach(es) as an option for pest risk management of fruit flies to facilitate trade of fruits. The standard applies to fruit flies (Tephritidae) of economic importance. 3. Systems Approach for Managing Pest Risks Associated With the
International Trade of Plants for Planting
This standard will provide guidelines for the development and evaluation of a systems approach as an option for pest risk management of the production and international movement of plants for planting
(excluding seeds) in commercial trade. 4. International Movement of Wood
This standard will provide guidelines for risk management for raw
(green) and treated wood and wood products moving in international trade through the application of phytosanitary measures. The standard will not apply to wood packaging material, which would remain wholly within the scope of ISPM No. 15. 5. Soil and Growing Media
This standard will provide guidance for the evaluation of risks associated with soil and growing media and describe phytosanitary integrated measures in a systems approach to manage the hazards of soil attached to imported plants from the country of origin upon arrival. 6. Revision of ISPMs 7 (Export Certification System) and 12 (Guidelines for Phytosanitary Certificates)
Existing ISPMs No. 7 and 12 have been reviewed for amendment to provide specific guidance on the procedures, which cover technical, legal, administrative and operational aspects, including export issues related to re-export and consignment in transit.
7. New Diagnostic Protocols in Draft Form
The following diagnostic protocols have been developed by the
Technical Panel on Diagnostic Protocols and are in draft form: Erwinia amylovora; Xanthomonas axonopodis pv. citri; Liberibacter spp.;
Xanthomonas fragariae; Phytophthora ramorum; Anastrepha spp.;
Bursaphelenchus xylophilus; Ditylenchus destructor/D. dipsaci; Plum pox virus; and Topoviruses (TSWV, INSV, WSMV).
For more detailed information on the above topics, which will be addressed by various working groups established by the CPM, contact Ms.
Julie E. Aliaga (see FOR FURTHER INFORMATION CONTACT above).
APHIS posts draft standards on the Internet (http:// www.aphis.usda.gov/import_export/plants/plant_exports/draft_ standards_4_comment.shtml) as they become available and provides information on the due dates for comments. Additional information on
IPPC standards is available on the IPPC Web site at http:// www.ippc.int/IPP/En/default.htm. For the most current information on official U.S. participation in IPPC activities, including U.S. positions on standards being considered, contact Ms. Julie Aliaga (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 Ms. Aliaga.
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/import_export/plants/plant_exports/draft_ standards_4_comment.shtml. 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 21-24, 2008, in
Guadalajara, Mexico. The NAPPO Executive Committee meeting will take place on October 20, 2008, and a session will be held on October 21, 2008, to solicit comments from industry groups so that suggestions can be incorporated into the NAPPO workplan for the 2009 NAPPO year. The
Associate Deputy Administrator for PPQ is a member of the NAPPO
Executive Committee. The Associate Deputy Administrator intends to participate in the proceedings and will discuss or comment on APHIS' position on any standard up for adoption or any proposals to develop new standards.
The work plan for 2008 was established after the October 2007
Annual Meeting in St. John's, Newfoundland, Canada. The Associate
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. The United States (i.e., 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. For each of the following panels, the United States will consider its position on any draft standard after it reviews a prepared draft. Information regarding the following NAPPO panel topics, assignments, activities, and updates on meeting times and locations may be obtained from the
NAPPO homepage at http://www.nappo.org or by contacting Ms. Julie E.
Aliaga (see FOR FURTHER INFORMATION CONTACT above). 1. Accreditation Panel
The panel conducted an in-depth audit of the Mexican system to comply with RSPM No. 8 (The Accreditation of Individuals to Sign
Federal Phytosanitary Certificates). It will develop a regional phytosanitary standard on authorization to perform other phytosanitary procedures (e.g., inspection, testing, and treatments). 2. Biological Control Panel
The panel will develop a list of approved biological control agents for importation into NAPPO countries and has developed guidelines for the importation and release of non-Apis pollinating insects into NAPPO countries. 3. Biotechnology Panel
The panel will revise RSPM 14 (Importation and Release into the
Environment of Transgenic Plants in NAPPO Member Countries) by consolidating Modules 1-3 into a single standard that provides clear guidance on risk assessment for transgenic plants for any intended use
(e.g., movement, confined release, unconfined release, and non- propagative use). It will develop a discussion paper on emerging issues related to transgenic products that could pose a risk to plant health
(e.g., pharmaceutical plants or trees, or other perennials) and determine the feasibility of developing regional standards. 4. Citrus Panel
The panel convened a NAPPO workshop on Citrus Greening
(Huanglongbing disease) in May 2008, and invited the participation of regional and international experts to exchange the latest research and regulatory information. The panel has revised RSPM 16 (Guidelines for the Importation of Citrus Propagative Material into a NAPPO Member
Country), and updated annexes. 5. Electronic Phytosanitary Certification Panel
The panel will exchange information as NPPOs of NAPPO countries complete their systems (e.g., security, documentation) to receive electronic phytosanitary certificate information; participate in other international fora on electronic certification (e.g., UN-CEFACT, IPPC, etc.); and initiate the pilot project for electronic phytosanitary certification within the NAPPO region. 6. Forestry Panel
The panel has drafted a NAPPO standard on preventing the entry of
Asian Gypsy Moth (AGM) into North America; will develop a NAPPO strategy for dealing with ongoing problems related to wood packaging that does not comply with ISPM No. 15 (Guidelines for regulating wood packaging material in international trade); develop a harmonized report of wood packaging compliance to post on the NAPPO Web site; and determine the need to establish a NAPPO standard for the regulatory
control of wooden handcrafts and outdoor furniture. 7. Fruit Panel
This panel has developed a NAPPO standard on determination and designation of host status of a commodity for fruit flies; will develop guidelines to determine the host range and adaptability of Rhagoletis spp. in the NAPPO region; prepare a specific case study to apply ISPM
No. 10 (Requirements for the establishment of pest free places of production and pest free production sites); provide training on PCR techniques for identification of the Mediterranean fruit fly, Ceratitis capitata; provide training on identification of Bactrocera spp. using classical systematics (morphological characters); and evaluate and recommend NAPPO diagnostic protocols and treatments. 8. Fruit Tree Panel
The panel will review the text of RSPM No. 25 (Guidelines for
International Movement of Pome and Stone Fruit Trees into a NAPPO
Member Country) and make any necessary changes to accommodate bacterial, fungal, insect and nematode pests; complete the insect and nematode annexes to RSPM No. 25; collaborate with the Grapevine Panel to develop a proposal for a diagnostic workshop on fruit tree and grapevine pests; and evaluate and recommend NAPPO diagnostic protocols and treatments. 9. Grains Panel
The panel has developed a strategic plan for NAPPO countries to prepare for the potential arrival of new races of black stem rust, e.g., Puccinia graminis f. sp. tritici race TTKS, in accordance with the framework developed in 2006/2007 and the pest fact sheet prepared by the NAPPO Pest Risk Analysis Panel; and will evaluate and recommend
NAPPO diagnostic protocols and treatments. 10. Grapevine Panel
The panel will complete the annexes concerning bacteria, fungi, and significant arthropod and nematode pests of grapevines for RSPM No. 15
(Guidelines for the Importation of Grapevines into a NAPPO Member
Country); review and make required changes to the annex on viruses in
RSPM No. 15; develop, in collaboration with the Fruit Tree Panel, a proposal for a diagnostic workshop on fruit tree and grapevine pests; and evaluate and recommend NAPPO diagnostic protocols and treatments. 11. Invasive Species Panel
The panel will complete the position paper describing NAPPO's role regarding invasive species; has developed the NAPPO standard for evaluating the invasiveness of plants for planting (screening tool) and the NAPPO standard for identifying and prioritizing pest introduction pathways (pathway analysis); and will continue outreach efforts to other national and international organizations in North America, particularly those related to the environment. 12. Pest Risk Analysis Panel
This panel will develop a NAPPO fact sheet on P. ramorum; collate a list of information requirements in order to conduct a NAPPO Pest Risk
Assessment (PRA) on the AGM (Lymantria dispar); conduct a NAPPO PRA on
AGM in collaboration with the NAPPO Forestry Panel; provide support, as required, to the Grains Panel to develop a strategic plan to deal with new races of black stem rust (Puccinia graminis) in North America; provide support, as required, to the Fruit Panel to develop guidelines to determine the host range and adaptability of Rhagoletis spp. in the
NAPPO region; and participate in the NAPPO Citrus Greening
(Huanglongbing disease) workshop. 13. Phytosanitary Alert System Panel
The panel will continue to post timely pest alerts on the NAPPO Web site; determine ways to improve official pest reporting through the
Phytosanitary Alert System (template, linkages, etc.); continue outreach efforts (including the NAPPO newsletter); and conduct an ongoing review of the Phytosanitary Alert Web page. 14. Plants for Planting
The panel will identify the constraints and recommend solutions for the implementation of RSPM No. 24 (Integrated Pest Risk Management
Measures for the Importation of Plants for Planting in NAPPO Member
Countries); draft guidelines, in collaboration with the NAPPO
Accreditation Panel, for the authorization of auditors involved in the implementation of RSPM No. 24; review the use of terms (e.g., certification, authorization) for consistency with the IPPC and ISPMs; and participate in IPPC activities related to the international standard on plants for planting. 15. Potato Panel
This panel will identify requirements for recognition of pest-free areas, pest-free places of production and pest-free production sites for Globodera pallida and G. rostochiensis; conduct the required five- year review of RSPM No. 3 (Requirements for the Importation of Potatoes into a NAPPO Member Country); determine the accuracy of RSPM No. 3,
Annex 5 (Pre-shipment Testing for PVYn), based on the current knowledge of the North American PVY complex; collaborate with the European PPO on harmonizing requirements for mini-tuber, micro-tuber, and mini-plantlet production; and evaluate and recommend NAPPO diagnostic protocols and treatments. 16. Standards Panel
The panel will coordinate the review of new and amended NAPPO standards and implementation plans; exchange and discuss comments on draft ISPMs within NAPPO and with other RPPOs to build consensus on draft ISPMs and other IPPC-related issues, as appropriate; review draft
RSPMs prepared by panels and make recommendations on their suitability for adoption by the Executive Committee; and review NAPPO position papers and policy documents to verify current relevance.
The PPQ Associate Deputy Administrator, as the official U.S. delegate to NAPPO, intends to participate in the adoption of these regional plant health standards, including the work described above, once they are completed and ready for such consideration.
The information in this notice contains 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 may become available following publication of this notice, go to the NAPPO Web site on the Internet at http:// www.nappo.org or contact Ms. Julie Aliaga (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 Ms. Aliaga. 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 Ms. Aliaga.
Done in Washington, DC, this 22nd day of July 2008.
Acting Administrator, Animal and Plant Health Inspection Service.
FR Doc. E8-17216 Filed 7-25-08; 8:45 am
BILLING CODE 3410-34-P