[Federal Register Volume 71, Number 90 (Wednesday, May 10, 2006)]
[Pages 27221-27224]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-7114]



Animal and Plant Health Inspection Service

[Docket No. APHIS-2005-0085]

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'' 
     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 (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: Mr. Narcy G. Klag, Program Director, 
International Standards, Phytosanitary Issues Management Team, PPQ, 
APHIS, 4700 River Road Unit 140, Riverdale, MD 20737-1236; (301) 734-



    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 
    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

[[Page 27222]]

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 
    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 
    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.

    \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.

* 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.

[[Page 27223]]

* 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 
*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.

[[Page 27224]]

*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.
 [FR Doc. E6-7114 Filed 5-9-06; 8:45 am]