[Federal Register Volume 71, Number 90 (Wednesday, May 10, 2006)]
[Notices]
[Pages 27221-27224]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-7114]
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DEPARTMENT OF AGRICULTURE
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.
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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 (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-
6799.
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
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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.
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\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.
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* 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.
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* 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.
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*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]
BILLING CODE 3410-34-P