E6-7114. Content of Bilateral Workplans

AGENCY:

Animal and Plant Health Inspection Service, USDA.

ACTION:

Notice and request for comments.

SUMMARY:

This notice is intended to provide background information about, and solicit public comments on, the use of bilateral workplans by the Animal and Plant Health Inspection Service's Plant Protection and Quarantine program. Bilateral workplans are agreements between Plant Protection and Quarantine, officials of the national plant protection organizations of foreign governments, and, when necessary, foreign commercial entities that specify in detail the phytosanitary measures that will comply with our regulations governing the import or export of a specific commodity.

DATES:

We will consider all comments that we receive on or before July 10, 2006.

ADDRESSES:

You may submit comments by either of the following methods:

• Federal eRulemaking Portal: Go to http://www.regulations.gov and, in the “Search for Open Regulations” box, select “Animal and Plant Health Inspection Service” from the agency drop-down menu, then click on “Submit.” In the Docket ID column, select APHIS-2005-0085 to submit or view public comments and to view supporting and related materials available electronically. Information on using Regulations.gov, including instructions for accessing documents, submitting comments, and viewing the docket after the close of the comment period, is available through the site's “User Tips” link.
• Postal Mail/Commercial Delivery: Please send four copies of your comment (an original and three copies) to Docket No. APHIS-2005-0085, 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-2005-0085.

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 [phone] 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:

Mr. Narcy G. Klag, Program Director, International Standards, Phytosanitary Issues Management Team, PPQ, APHIS, 4700 River Road Unit 140, Riverdale, MD 20737-1236; [phone].

SUPPLEMENTARY INFORMATION:

Background

The Animal and Plant Health Inspection Service (APHIS) of the U.S. Department of Agriculture is responsible for protecting the health of U.S. agriculture. As part of this responsibility, APHIS' Plant Protection and Quarantine (PPQ) program, the national plant protection organization (NPPO) of the United States, regulates the importation, exportation, and interstate movement of plants, plant products, biological control organisms, noxious weeds, and articles that could harbor plant pests or noxious weeds to prevent the introduction into or the dissemination within the United States of plant pests or noxious weeds.

This notice is intended to provide background about, and solicit public comments on, PPQ's use of bilateral workplans. A bilateral workplan is an agreement between PPQ, officials of the NPPO of a foreign government, and, when necessary, foreign commercial entities that specifies in detail the phytosanitary measures that will comply with our regulations governing the import or export of a specific commodity. Bilateral workplans apply only to the signatory parties and establish detailed procedures and guidance for the day-to-day operations of specific import/export programs. Bilateral workplans also establish how specific phytosanitary issues are dealt with in the exporting country and make clear who is responsible for dealing with those issues. The content of bilateral workplans is described in detail later in this document.

Need for Bilateral Workplans

PPQ enters into bilateral workplans to implement both U.S. import and export programs. There is no universal rule for when a bilateral workplan is needed. A workplan may be requested by PPQ, by a foreign cooperator, or by U.S. importers or exporters. Typically, when importing a commodity that involves specific inspections, treatments, or mitigations to be conducted or applied in a foreign country, a bilateral workplan is executed between the importing and exporting countries. A bilateral workplan is usually not required when an import is authorized entry into the United States subject only to general requirements, such as inspection and/or treatment upon arrival in the United States. Bilateral workplans for U.S. exports may be required as a condition of importation or at the request of the importing country to facilitate the entry of the commodity.

Negotiations with a foreign country or other region regarding the content of bilateral workplans generally cannot take place until the importing country has determined what risk mitigation measures must be applied to the import in question. These determinations are based on the best available science, experience, and other evidence, including the findings of a pest risk analysis or analyses and inspection and observation of imports that have occurred in the past.

Negotiations regarding the content of bilateral workplans take place between PPQ and the NPPO of the importing/exporting country.

Each bilateral workplan is unique to the commodity being imported or exported and its country or region of origin. Although one bilateral workplan may be substantially the same as another, or even identical, bilateral workplans cannot be transferred from one commodity to another or from one country or region to another; agreement must be reached separately for each commodity, country, or region. Bilateral workplans are valid for the period of time specified in the workplan, which is typically 1 to 2 calendar years.

Basis for Use of Bilateral Workplans in International Trade Agreements

Bilateral workplans are used by importing and exporting countries to clarify and assign responsibilities and to establish and formalize phytosanitary import/export program operations. The United States is a member of the World Trade Organization (WTO). Created by the Uruguay Round of negotiations under the General Agreement on Tariffs and Trade, the WTO is the international institutional framework for governing trade relations among its members in all matters for which a final agreement has been reached, including non-tariff barriers, natural resource products, agriculture, dispute settlement, and other topics. Among other things, the WTO Agreement on the Application of Sanitary and Phytosanitary Measures (the SPS Agreement) obligates members to base any phytosanitary measures they may require on an assessment of risk as appropriate to the circumstances and to make those requirements transparent.

In the Uruguay Round Agreements Act of 1994, Congress approved U.S. membership in the WTO. This Act also amended title IV of the Trade Agreements Act of 1979 (19 U.S.C. 2531, et seq.) to require the President to designate an agency to be responsible for informing the public of the sanitary and phytosanitary standard-setting activities of various international standard-setting organizations.

“International standard” is defined in 19 U.S.C. 2578b as any standard, guideline, or recommendation: (1) Adopted by the Codex Alimentarius Commission regarding food safety; (2) developed under the auspices of 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 or the member countries of the WTO.

The IPPC is a multilateral convention intended to secure effective action to prevent the spread and introduction of plant pests and noxious weeds and to promote appropriate measures for their control. The IPPC operates under the authority of the Food and Agriculture Organization (FAO) of the United Nations, and the members of the Secretariat of the IPPC are appointed by the FAO. The IPPC is implemented by NPPOs in cooperation with regional plant protection organizations, the Interim Commission on Phytosanitary Measures, and the Secretariat of the IPPC. The IPPC is administered at the national level by plant quarantine officials, whose primary objective is to safeguard plant resources from injurious pests and noxious weeds.

NAPPO, a regional plant protection organization created in 1976 under the IPPC, coordinates the efforts among the NPPOs of Canada, the United States, and Mexico to protect their plant resources from the entry, establishment, and spread of harmful plant pests and noxious weeds, while facilitating intra- and inter-regional trade.

NAPPO established guidelines for bilateral workplans in October 2003. Copies of the guidelines, titled “Regional Standards for Phytosanitary Measures No. 19, Guidelines for Bilateral Workplans” (October 19, 2003), may be obtained on the Internet at http://www.nappo.org/​Standards/​NEW/​RSPM19-e.pdf,, or by contacting the person listed under FOR FURTHER INFORMATION CONTACT.

PPQ has developed guidelines for the content of bilateral workplans, which are listed and discussed in detail below. These guidelines are harmonized with the NAPPO guidelines and the principles of the SPS Agreement. It is not necessary to include every item listed in the guidelines in every bilateral workplan. Only items designated by an asterisk must be included. However, all the items listed below must be considered for inclusion and must be made part of a final bilateral workplan if they apply to the particular situation being addressed by that workplan. Each included item should be dealt with in a separate section of the workplan.

Guidelines for Bilateral Workplans

* 1. Title

Each workplan must have a title. The title should accurately and succinctly describe the subject of the workplan, for example: Operational Workplan for [commodity] from [country]. In some cases, the title may describe requirements for two-way trade between the United States and another country.

* 2. Pests of Concern

Each workplan must include a list of pests or noxious weeds of concern. The list must specify the regulated pests or noxious weeds for the importing country for the commodity covered by the workplan.

* 3. Definitions, Abbreviations, and Acronyms

All significant terms used in the workplan must be defined in order to prevent confusion and disagreements later when the workplan is in effect. As much as possible, the workplan should define terms the same way they are defined in the FAO Glossary of Phytosanitary Terms, International Standards for Phytosanitary Measures (ISPM) Publication No. 5,^[1] and the NAPPO Glossary of Phytosanitary Terms.^[2] Any deviations and differences from those terms should be made clear and explained in the workplan.

* 4. Participants

All participants in the importing and exporting country must be clearly identified in the workplan. Participants may include:

• Public authorities who will apply phytosanitary measures, including phytosanitary certification;
• Parties who will be involved with any aspect of trade in the commodity, including packinghouses, storage facilities, transportation companies, etc.; and
• Non-public parties who will participate in applying phytosanitary measures or related activities.

* 5. Responsibilities of the Participants

The workplan must specify each participant's responsibilities, including financial obligations, that contribute to meeting the goals of the workplan.

* 6. Relevant Authority

All legislation, regulations, directives, and policies that are relevant to the workplan must be specifically identified. Provisions of ISPMs and Regional Standards for Phytosanitary Measures that are relevant to the workplan must be specifically identified and followed wherever possible.

* 7. Implementation of Phytosanitary Measures

Phytosanitary measures should ensure that the exported commodity is free of regulated pests specified by the importing country and meets the entry requirements of the importing country. How the phytosanitary measures in the workplan will be implemented must be described in detail. There are many possible phytosanitary measures. Measures identified in bilateral workplans may include pre-harvest measures, post-harvest measures, and safeguarding.

7.1 Pre-Harvest Measures

Pre-harvest measures are taken at the production site or surrounding areas, before a crop is harvested. Pre-harvest measures may include selection of plants for planting, surveys, inspections, treatments, tests, and other phytosanitary measures. A description of all required pre-harvest measures and how they are to be implemented must be included in the workplan.

If any required pre-harvest measures relate to pest-free places or production sites, they must meet the requirements of the appropriate ISPM. The appropriate standards are usually ISPM No. 4, “Requirements for the establishment of pest free areas” and/or ISPM No. 10, “Requirements for the establishment of pest free places of production and pest free production sites.” If any pre-harvest measures involve sampling and testing, the appropriate procedures must be specified in the workplan.

7.2 Post-Harvest Measures

Post-harvest measures are measures taken after a crop is harvested, but prior to shipment. Post-harvest measures may include inspections, treatments, tests, and other phytosanitary measures. Inspections can be visual and/or samples can be taken and diagnostically analyzed when appropriate. Regardless of the measures chosen, if post-harvest measures are included in the workplan, they must be explained in detail. For example, if sampling is required for inspection, the sampling methodology and sample size must be specified in the workplan.

7.3 Safeguarding

If safeguarding is required, the workplan must specify the type of safeguarding required and when it must be applied. Safeguarding measures may include, but are not limited to, special packaging, storage requirements, sealing, and limited ports of entry.

8. Point of Entry

If entry into the importing country is limited to specific points of entry, whether for biological or operational reasons, they must be listed in the workplan.

9. Documentation and Labeling for Phytosanitary Purposes

If any specific documentation and/or labeling is required for phytosanitary purposes, the requirements must be specified, in detail, in the workplan. Documentation and labeling for phytosanitary purposes includes phytosanitary certificates (with or without additional declarations), labels of all types, and other specified documents. If a phytosanitary certificate is required, the workplan must specify that issuance of the certificate must comply with ISPM No. 12, “Guidelines for phytosanitary certificates.”

If an additional declaration is necessary, the required language must be specified in the workplan. If any label is necessary, the requirements must be explained in detail in the workplan. For example, any required sizes, colors, content, or layout must be explained.

10. Auditing

The NPPO of the importing country may undertake audits of the procedures and the certification of phytosanitary measures applied in the exporting country. The process for requesting access and the frequency and characteristics of the audit should be specified. Auditing can take place in either the exporting country or at ports of entry in the importing country.

11. Review

If it is anticipated that the workplan will be reviewed periodically, this should be specified in the workplan. The timing and/or frequency of reviews should be specified if possible.

*12. Unanticipated Situations/Disagreements

Unanticipated situations and disagreements can arise during the course of operating import/export programs. The workplan must include, at a minimum, a communication plan to address these problems.

*13. Effective Dates

The exact date the workplan becomes effective must be included. If the workplan will be effective for a limited time, that information must also be included, with specific dates if possible.

*14. Noncompliance and Resulting Actions

14.1 Examples of Noncompliance

There are many types of noncompliance. Examples include detection of quarantine pests, presence of regulated nonquarantine pests above specified tolerances, inadequate or missing documentation, misapplication of required phytosanitary measures, and failure to comply with the workplan in any particulars. The workplan must categorize occurrences that could result in noncompliance with regard to how severely they impact the confidence of the signatories to the workplan that the requirements of the workplan are being appropriately implemented and followed. The workplan must also state the specific occurrences that are included in each of the categories. For example, a workplan might include critical, major, and minor categories for occurrences that could result in noncompliance. That workplan would also provide lists of the occurrences that would constitute a critical violation of the workplan, the occurrences that would constitute a major violation, and the occurrences that would constitute a minor violation.

*14.2 Actions Taken for Noncompliance

The workplan must specify actions to be taken for noncompliance with phytosanitary requirements contained in the workplan. Actions should be proportionate to the seriousness of the noncompliance. The strongest action—terminating the workplan or excluding a participant—should be reserved for the most serious noncompliance. Possible actions include terminating the workplan, suspending or excluding a participant, suspending the workplan, and other appropriate actions. Actions taken for noncompliance must be specified and fully explained in the workplan, so that all participants are aware of the consequences for noncompliance.

*14.3 Notification of noncompliance

The workplan must include procedures for notifying participants of any noncompliance and the proposed action to be taken as a result. Timelines for notification and for responses may be specified in the workplan, and must comply with ISPM No. 13, “Guidelines for the notification of noncompliance and emergency action.”

*14.4 Suspension and Reinstatement

The workplan must include requirements for reinstating a participant who has been suspended for noncompliance and requirements for reinstating a workplan that has been suspended. The requirements must be specified and fully explained in the workplan.

15. Additional Documentation

Examples of additional documents, such as treatment certificates and inspection reports, should be attached to the workplan as appendices if they are necessary.

We are inviting public comment on the guidelines provided above, as well as comments or queries on any other aspect of APHIS' use of bilateral workplans.

Done in Washington, DC, this 4th day of May 2006.

Kevin Shea,

Acting Administrator, Animal and Plant Health Inspection Service.

Footnotes

1.  ISPMs may be viewed on the World Wide Web at https://www.ippc.int/​IPP/​En/​default.jsp;​; click on the “Standards” link.

2.  See http://www.nappo.org/​Standards/​REVIEW/​RSPM5-e.pdf.