[Federal Register Volume 64, Number 191 (Monday, October 4, 1999)] [Notices] [Pages 53657-53661] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: 99-25722] ======================================================================== 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. ======================================================================== Federal Register / Vol. 64, No. 191 / Monday, October 4, 1999 / Notices [[Page 53657]] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF AGRICULTURE Animal and Plant Health Inspection Service [Docket No. 99-046-1] International Sanitary and Phytosanitary Standard-Setting Activities AGENCY: Animal and Plant Health Inspection Service, USDA. ACTION: Notice and solicitation of 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 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 your comment and three copies to: Docket No. 99- 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. 99-046-1. 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 rules, are available on the Internet at http:// www.aphis.usda.gov/ppd/rad/webrepor.html. FOR FURTHER INFORMATION 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; or e-mail: John.K.G[email protected]. 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 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 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 institutions. Our intent is to describe 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. 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 153 member nations, each of which is represented by a delegate who, in most cases, is the [[Page 53658]] 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 through the sharing of scientific research among its members. The major functions of the OIE are to collect and disseminate information about distribution and control 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 disease-free status of member countries, categorizes animal diseases with respect to their international significance, publishes bulletins on global disease status and timely reviews of pertinent animal health issues, and provides animal disease control guidelines to member countries. Positions, policies, and standards established by the OIE can be adopted by consensus or by vote of the delegates upon recommendations from various commissions and working groups within the OIE. These various commissions and working groups undertake the initial analysis and preparation of draft standards. Drafts are then circulated to member countries for 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 Paris, France, May 22-26, 2000. The Deputy Administrator for APHIS' Veterinary Services is the U.S. delegate to the OIE. The Deputy Administrator intends to participate in the proceedings. The agenda is expected to include the following items: Election of Officers Current officers of the various OIE commissions and the current Director General will have completed their respective terms of office. OIE members will elect new officers. The Director General serves for 5 years while other officers serve for 3 years. Standards up for Adoption or ConsiderationScrapie: Revisions to the OIE Code, Chapter 3.3.8, on scrapie disease. Bee diseases: Revisions to the OIE Code, Chapter 3.8.1-- 3.8.5. Current Work Program Working groups will report their progress to the General Session. For updates on meeting times and for information on the working groups that becomes available following publication of this notice, contact Dr. Gary Colgrove, VS, APHIS, 4700 River Road Unit 38, Riverdale, MD 20737-1231; (301) 734-8364; or e-mail: Gary.S.C[email protected]. The following describes the current undertakings of the working groups, it is not a list of standards up for consideration or adoption: Zoning and regionalization: Revisions to the OIE Code, Chapter 1.4.4, on regionalization will be prepared by the next meeting of the Code Commission. It is uncertain whether this revised chapter will be ready for adoption by the General Session in May 2000. Model certificate for milk and milk products: An effort will be made to develop guidelines for certifying milk and milk products. The International Dairy Federation will attempt to draft such guidelines by September 1999. Enzootic bovine leukosis: Revisions to the OIE Code, Chapter 3.2.4. International trade in animals, organs, tissues, or cells intended for xenotransplantation: The OIE working group on biotechnology will prepare a document on this topic for consideration by the May 2000 General Session. Equivalence: A proposal for OIE Code language on this topic will be developed and circulated among members for comments. Classical swine fever: An ad hoc group will examine possible revisions to the OIE Code, Chapter 2.1.13. Newcastle disease: An ad hoc group will be formed to examine possible revisions to the OIE Code, Chapter 2.1.15. Paratuberculosis: There may be revisions made to the OIE Code, Chapter 3.1.6. Bovine Spongiform Encephalopathy (BSE) Each spring, the chapter of the OIE Code concerning BSE (3.2.13) is modified, clarified, and improved. However, major questions remain. Expert groups will continue to evaluate the chapter. Portions still under study include: Criteria for meeting the OIE definition of a ``BSE Provisionally Free Country.'' Procedures and measures for importing cattle from a ``BSE Provisionally Free Country or Zone.'' Procedures and measures for importing cattle from a country or zone with a ``high incidence of BSE.'' Criteria for importing fresh meat (boned or deboned) and other meat products from cattle from a country or zone with a ``low incidence of BSE.'' Criteria for importing tallow intended for food, feed, fertilizers, cosmetics, pharmaceuticals, or medical devices from countries ``not affected by BSE.'' Specifically, rendering procedures are under study. Other Major OIE Topics The May 2000 General Session will address two other major topics, for which additional standards are not expected to be developed and presented for adoption at the May 2000 General Session: Principles of prevention and management of aquatic animal diseases. Advances in the control and eradication of tuberculosis in domestic and wild animals. More information on OIE standards is available on the OIE web page at http://www.oie.int. The information in this notice includes all the information available to us on OIE standards currently under development or consideration. For updates on meeting times and for information on the working groups that becomes available to us following the publication of this notice, contact Dr. Gary Colgrove, VS, APHIS, 4700 River Road Unit 38, Riverdale, MD 20737-1231; (301) 734-8364; or e-mail: Gary.S.C[email protected]. 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 [[Page 53659]] 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 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. It is projected that the amended IPPC will enter into force, replacing the existing text, by the year 2000. 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 USDA's Animal and Plant Health Inspection Service (APHIS), Plant Protection and Quarantine (PPQ) unit. Currently, IPPC standards may be proposed in a number of ways. The IPPC Secretariat may initiate the development of a draft standard by forming a working group to develop a standard deemed a priority by ICPM members. Draft standards or discussion papers may also be submitted to the IPPC Secretariat for consideration by regional or national plant protection organizations or other interested parties. The IPPC Secretariat refers draft standards to the Committee of Experts on Phytosanitary Measures (CEPM), which considers the drafts and recommends action. Drafts approved by the CEPM are then submitted to member countries for consultation and comment. Comments made during country consultation are then considered by the Secretariat, which revises the standard before resubmitting it to the CEPM. If the CEPM approves the revised draft, it is submitted to the ICPM, the governing body of the IPPC, for adoption. Each member country is represented on 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 vote on proposed standards or other initiatives. 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 basis for many of the standards adopted to date. This notice describes each of the IPPC standards currently under consideration or up for adoption. Access to the full text of each standard will be available electronically on the APHIS Internet web page at http://is.aphis.usda.gov/ppq/standard/#TOP. Interested individuals may review and provide comments on the standards found on this web page. The next ICPM meeting is scheduled for October 4-8,1999. The Deputy Administrator for APHIS' Plant Protection and Quarantine is the U.S. delegate to the ICPM. The Deputy Administrator intends to participate in the proceedings. The agenda is expected to include the following items: Report of the Chair The ICPM chairman will summarize IPPC activities from the past year (e.g., working group activities and meetings), report on outstanding issues, and highlight areas of particular interest confronting members of the ICPM. Standard-Setting Priorities The Secretariat will report on topics and priorities for standards identified by ICPM members and regional plant protection organizations. Other topics identified by the Secretariat will also be noted. A working group will be formed to review the information and recommend a work program for the ICPM to give to the Secretariat. Standards up for Adoption or Consideration Requirements for the establishment of pest-free places of production and pest-free production sites: This standard describes the requirements for the establishment and use of pest-free places of production and pest-free production sites as pest risk management options for meeting phytosanitary requirements for the importation of plants, plant products, and other regulated articles. Revised Glossary of Phytosanitary Terms: The Glossary of Phytosanitary Terms has been updated and new terms have been added after thorough review by a special working group and the CEPM. The revised glossary represents the first revision of an established IPPC standard returned for approval by the ICPM. Reports From Various Working Groups Standard-setting procedures: A working group was formed at the first ICPM meeting in November 1998 to analyze the current standard-setting procedure to determine whether it requires revision and, if so, to propose a revised procedure to the second ICPM meeting scheduled for October 1999. The chairman of this working group is expected to report on the outcome of those deliberations. A report will be distributed for review, discussion, and approval. If agreed, procedures for standard setting will be annexed to the Rules of Procedure for the ICPM. Dispute settlement provisions: A working group was formed at the first ICPM meeting in November 1998 to develop rules and procedures for the operation of the nonbinding dispute resolution procedures contained in the IPPC. A report will be distributed for review, approval, and discussion of further steps. Pest reporting requirements: The Secretariat will report on the mechanisms in place, or proposed, that facilitate pest reporting obligations. Strength of measures: The Secretariat will report on issues associated with the understanding and implementation of the concept of strength of measures. Work Program for Harmonization Standard-setting: The Secretariat will report on the status of standard-setting activities and the working group will report on topics and priorities for the upcoming work program. Information exchange: The Secretariat will report on the status of information exchange activities. Technical assistance: The ICPM chairman has held discussions with [[Page 53660]] interested delegations on the subject of technical assistance for developing countries. The chairman will report on initiatives aimed at developing a technical assistance program in line with the technical cooperation aspects of the IPPC. Status of IPPC Acceptance of the new revised text: Update and report by members Interim measures: --Members designate their official contact points. --Members report on the voluntary use of the new phytosanitary certificate. More information on IPPC standards is available on the FAO web page at http://www.ippc.int. The information in this notice includes all the information available to us on IPPC standards currently under development or consideration. For updates on meeting times and for information on the working groups that becomes available following publication of this notice, contact Dr. Richard Dunkle, Deputy Administrator, PPQ, APHIS, USDA, room 302-E, Whitten Building, 14th Street and Independence Avenue, SW., Washington, DC 20250. 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 by Canada, Mexico, and the United States, which may suggest revisions. 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 19-21, in Cancun, Mexico. The Executive Committee meeting will take place on October 17, and a special session will be held on October 18, where industry groups can bring issues to the attention of the Executive Committee. The Deputy Administrator for APHIS' Plant Protection and Quarantine is the U.S. delegate to NAPPO. The Deputy Administrator intends to participate in the proceedings. The agenda will include the following items: Standards up for Adoption or Consideration A revised laboratory accreditation standard will be presented to the Executive Committee for consideration and adoption. A paper entitled, ``A Harmonized Procedure for Morphologically Distinguishing Karnal Bunt and the Ryegrass Bunt,'' which has been prepared by the NAPPO Grains Panel, will be presented for Executive Committee approval. Updates on NAPPO Panel Activities Working panels will report their progress to the General Committee. For updates on meeting times and for information on the working panels that becomes available following publication of this notice, contact Dr. Richard Dunkle, Deputy Administrator, PPQ, APHIS, USDA, Room 302-E, Whitten Building, 14th Street and Independence Avenue, SW., Washington, DC 20250. The following is a summary of current panel charges as they relate to the ongoing development of standards and does not include standards up for consideration or adoption: Accreditation Panel (Laboratory Accreditation) Develop an inventory of laboratory tests, analyses, and identification done in support of plant health regulatory activities. Biological Control Panel Develop NAPPO guidelines for the release of non-native entomophagous agents for the biological control of weeds. Biotechnology Panel Develop a NAPPO standard for the review of products of biotechnology which focuses on the assessment of the potential impact on plant resources, including risk assessments, environmental assessments, and whether the product itself can become a pest of plants. Citrus Panel Continue development of a NAPPO citrus standard. Forestry Panel Continue development of a NAPPO dunnage standard. Fruit Fly Panel Describe pest free areas for the Mexican fruit fly (Anastrepha ludens) in the NAPPO region and identify areas of low presence and susceptible areas for the establishment of the pest. Grapevine Panel Continue development of a NAPPO grapevine standard. Fruit Tree Panel Initiate development of a NAPPO malus and prunus standard. Pest Risk Analysis Panel Provide PRA support to the NAPPO Forestry and Grains Panels, as requested. Work with other plant protection organizations to develop a global potato standard. Standards Panel Coordinate responses to the North American member on the Committee for Experts for Phytosanitary Measures on draft international standards for phytosanitary measures (ISPM's) and contribute to the development of a draft ISPM on regulated nonquarantine pests. Provide updates on standards in the NAPPO newsletter. Presentations Biodiversity convention: Speakers will provide an overview of the objectives of the biodiversity convention. Biosafety protocol: Speakers will explain the process involved in developing the biosafety protocol. Various countries' positions and approaches will be discussed. An environmental spokesperson will talk about the environmental aspects of the biosafety protocol. Risk management: A speaker from academia will explore various societal values and expectations, as well as other factors that are considered in risk management. WTO dispute settlement: Speakers will review outcomes of recent WTO dispute settlement cases, highlighting the panel conclusions and lessons to be learned from these disputes. More information on NAPPO standards is available on the NAPPO web page at http://www.nappo.org. 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, contact Dr. Richard Dunkle, Deputy Administrator, PPQ, APHIS, USDA, Room 302-E, Whitten Building, 14th Street and Independence Avenue, SW., Washington, DC 20250. [[Page 53661]] Done in Washington, DC, this 27th day of September 1999. Craig A. Reed, Administrator, Animal and Plant Health Inspection Service. [FR Doc. 99-25722 Filed 10-1-99; 8:45 am] BILLING CODE 3410-34-P