[Federal Register Volume 71, Number 103 (Tuesday, May 30, 2006)]
[Rules and Regulations]
[Pages 30563-30568]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-8238]


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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

7 CFR Part 319

[Docket No. 02-132-2]
RIN 0579-AB83


Requirements for Requests To Amend Import Regulations

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Final rule.

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SUMMARY: We are establishing regulations governing the submission of 
requests for changes in our regulations that restrict the importation 
of plants, plant parts, and plant products. We are taking this action 
because, despite existing non-regulatory guidance on the submission of 
requests, few applicants provide the basic information we require to 
properly consider their requests. The new regulations will help ensure 
that we are provided with the information we need to prepare a risk 
analysis and/or other analyses that evaluate the risks and other 
effects associated with a proposed change to the regulations. This 
information is needed for us to effectively consider the request, and 
submission of the information at the time the request is made allows us 
to proceed with our consideration of the request in a timely manner.

DATES: Effective Date: June 29, 2006.

FOR FURTHER INFORMATION CONTACT: Mr. Robert L. Griffin, Director, Plant 
Epidemiology and Risk Analysis Laboratory, Center for Plant Health, 
Science, and Technology, PPQ, APHIS, 1730 Varsity Drive, Suite 300, 
Raleigh, NC 27606; (919) 855-7400.

SUPPLEMENTARY INFORMATION:

Background

    The regulations contained in 7 CFR part 319 (referred to below as 
the regulations) prohibit or restrict the importation of plants, plant 
parts, and plant products into the United States in accordance with the 
authority conferred on the Secretary of Agriculture by the Plant 
Protection Act (7 U.S.C. 7701 et seq.). The Animal and Plant Health 
Inspection Service (APHIS) is the United States Department of 
Agriculture (USDA) agency responsible for (1) enforcing the part 319 
regulations and (2) considering requests to amend the part 319 
regulations to allow the importation of plants, plant parts, or plant 
products that are not currently

[[Page 30564]]

allowed importation under the regulations.
    On October 28, 2004, we published in the Federal Register (69 FR 
62823-62829, Docket No. 02-132-1) a proposal to amend the regulations 
by establishing regulations governing the submission of requests to 
change the part 319 import regulations. We proposed this action 
because, despite our publication on June 19, 2001, of a notice in the 
Federal Register (66 FR 32923-32928, Docket No. 00-082-1) containing 
guidance on the submission of information in support of commodity 
import requests, and despite other existing guidance on this subject, 
few applicants provide the basic information we require to properly 
consider their requests. The proposed regulations were designed to help 
ensure that we are provided with the information we need to prepare a 
risk analysis and/or other analyses that evaluate the risks and other 
effects associated with a proposed change to the regulations. This 
information is needed for us to effectively consider the request, and 
the submission of the information at the time the request is made 
allows us to proceed with our consideration of the request in a timely 
manner. Without the information, we are unable to effectively consider 
such requests.
    We solicited comments concerning our proposal for 60 days ending 
December 27, 2004. We received nine comments by that date. The comments 
came from private citizens, nursery owners and growers in the United 
States, a State agriculture department, and foreign agriculture 
agencies. The comments were generally supportive of the proposed 
changes but did raise several concerns related to the proposed rule. 
These issues are discussed below.
    Issue: The information required when import requests are submitted 
should include the proposed destination of the commodities (e.g., 
specific States) to facilitate a more objective analysis of risk.
    Response: Exporters most often request access to the entire United 
States or just the continental United States, and the scope of our pest 
risk analysis (PRA) may reflect that request. We often decide to expand 
or reduce the scope based on several factors, including in particular 
the existence of other similar requests or our past experience with 
trade of the commodity in question. In some cases, an outcome of the 
PRA process might be a recommendation for limited distribution within 
the United States as a mitigation measure, but in those cases it is 
APHIS, not the exporter, that designates the area into which the 
particular article may be distributed. On rare occasions, an exporter 
may request access to only a portion of the United States (e.g., to 
areas that cannot support fruit fly populations); in such cases, 
limited distribution is an important element of the import request and 
is highlighted accordingly in the request. Even in such cases, however, 
it is likely that APHIS would assess the risks associated with the 
article in relation to the entire United States or the continental 
United States to ensure that limited distribution can be expected to 
serve as an adequate mitigation measure.
    Issue: If a commodity is already allowed entry into the United 
States, but is only allowed to be distributed in certain areas of the 
United States or may only be exported from certain areas in the 
exporting country, a list of all pests and diseases associated with the 
commodity proposed for exportation to the United States should not be 
required.
    Response: We agree that in the case of a commodity already allowed 
entry under one set of mitigations, it may not be necessary for us to 
prepare a new or updated PRA in order to consider a request to allow 
entry of the same commodity under a different set of mitigations. In 
such a case, an update to or confirmation of previously submitted pest 
and disease information, rather than an entirely new submission, may be 
appropriate. APHIS will decide on a case-by-case basis whether a 
complete, formal risk analysis may be required, or whether our 
understanding of the pests in the exporting country is sufficient to 
allow us to proceed with our consideration of the request without a new 
or updated risk assessment. For example, in the case of a request to 
expand distribution of a commodity to a new region (e.g., to allow an 
article to be imported into the whole United States when imports are 
currently limited to the continental United States), we might need to 
conduct additional pest risk analysis and would need more information. 
We have added a footnote to Sec.  319.5(d)(4) in this final rule to 
point out that an update may be appropriate and that a determination as 
to whether or not that is the case may be obtained by contacting APHIS. 
Contacting APHIS will allow us to identify the specific information 
that would aid in our consideration of the request. It is not possible 
for us to anticipate and specify in advance all of the possible 
information that may be helpful to evaluating a particular change in 
the status of a specific commodity. For instance, a change associated 
with a pest free area will require data regarding pest freedom. The 
exact nature (quantity and quality) of data required for this purpose 
will vary with pests, commodities, and origins.
    Issue: The information requested under ``Additional Information'' 
should be made optional for the exporting country, as some of the 
information requested is very specific and there may not be research 
available to provide the necessary details.
    Response: The information designated by this rule as ``required 
information'' will be needed at minimum for all commodities. The 
information designated as ``additional information'' will vary for 
specific requests and may be critical for determining whether certain 
commodities should or should not be allowed to enter the United States. 
APHIS does not intend for all the additional information to be provided 
for every commodity, but some of it may be required for certain 
commodities, and it is normally in the exporter's interest to provide 
such information because it provides details essential to a proper 
analysis. For example, the susceptibility of particular varieties of 
fruit to pests can be an important factor in determining host status. 
In most cases, the variety is not important, but it is a critical issue 
when the variety is a factor in determining host status. Papayas and 
avocados in general may represent a risk of introducing fruit flies, 
but Solo papayas and Hass avocados are poor hosts for fruit flies. 
Similarly, the unique characteristics of a production area, such as its 
physical and climatological description, may be important. Altitude and 
physical barriers such as mountains are likely to play a role in 
understanding why the pests of concern are not a concern in a 
particular area. This is important information for the recognition of 
pest free (or low prevalence) areas.
    Rather than make the additional information optional, as suggested 
by the commenter, we are clarifying in this final rule that such 
information is not required to be submitted with the initial request, 
as does the required information, but that APHIS may request any of the 
additional information if it determines it is necessary for completion 
of a PRA in accordance with international standards, and because the 
information is not available from other sources. In such cases, APHIS 
will notify the plant protection organization of the exporting country 
in writing as to what specific additional information is required. This 
additional information applies to those requests where APHIS needs to 
understand additional details in order to assess the specific situation 
accurately in the PRA. For example, details such as

[[Page 30565]]

whether a fruit is washed with soap, waxed, and culled or only rinsed 
may be important for determining if certain pests remain associated 
with fruit or not. In the proposed rule, the additional information 
items were presented in the Supplementary Information section and not 
in the proposed regulatory text at the end of the document. In this 
final rule, we include the additional information items, along with the 
above explanation as to when and how APHIS may request additional 
information, in the text of Sec.  319.5 as paragraph (e). The 
information regarding the availability of additional guidance that had 
been paragraph (e) in the proposed rule is in a new paragraph (f) in 
this final rule.
    Issue: The required information would be impossible for the 
discoverer of new species or the small seed importer to provide and 
would therefore close down research, plant exploration, and new variety 
introduction. This would injure the small operations in the ornamental 
horticulture business as well as government crop researchers, botanical 
gardens, and pharmaceutical companies.
    Response: This final rule applies only to applications to change 
the existing regulations and would primarily affect the importation of 
fruits and vegetables; it would not affect imported nursery stock 
unless it was planted in a growing medium. Bareroot plants, seeds, 
cuttings, and other propagative materials could still be imported 
without a risk assessment provided these materials are not listed among 
the items specifically prohibited in the regulations in ``Subpart--
Nursery Stock, Plants, Roots, Bulbs, Seeds, and Other Plant Products'' 
(Sec. Sec.  319.37 through 319.37-14).
    While the rule is not intended to restrict small imports, it may 
limit the ability of individuals without resources who wish to export 
unique fruits and vegetables to the United States to pursue a request 
to do so on their own. However, every country that enters into the 
World Trade Organization (WTO) must have the infrastructure in place to 
support their exporters. The exporting country is obliged to certify 
its exports and will need to (1) be able to provide essentially the 
same information for export certification purposes, and (2) understand 
the pest situation associated with the commodities it is certifying for 
export. The rule serves to ensure that the NPPO of the exporting 
country is officially involved and able to meet its export obligations.
    New species for which there is little information available may 
indeed be adversely affected simply because the uncertainty amplifies 
the risk. We do not agree that this rule closes down research or 
injures small operations since it is incumbent on both the importing 
and exporting countries to ensure that trade in new commodities does 
not pose an unacceptable phytosanitary risk.
    Issue: Because an extensive commodity-initiated PRA needs to be 
completed by U.S. authorities before a particular commodity can be 
imported, and that commodity is prohibited importation until then, the 
United States is effectively taking phytosanitary measures which are 
not technically justified and are therefore not in alignment with 
Article 5, section 1 of the WTO's Agreement on the Application of 
Sanitary and Phytosanitary Measures (SPS Agreement). As part of 
international standards, prohibition of commodities is regarded as a 
last resort, to be used only when no other satisfactory measure to 
reduce risk to an acceptable level can be found. USDA should therefore 
adapt its procedures in accordance with international agreements and 
standards, such as by granting provisional permission to import new 
commodities subject to temporary measures such as the requirement for a 
phytosanitary certificate. Final measures could be imposed following 
the completion of a PRA.
    Response: In this case we make a distinction between commodities 
that are ``prohibited'' and disciplined by Article 5 of the SPS 
Agreement, and commodities that are ``not yet approved'' or ``pending 
evaluation'' and disciplined by Annex C of the SPS Agreement. Articles 
that are prohibited have been evaluated and prohibition is the measure 
that has been determined to be appropriate. This status may be changed 
based on new information and a reevaluation using a PRA. Likewise, pest 
risk analysis is used to evaluate the risk associated with a request 
for a new commodity not previously evaluated.
    Many commodities are excluded from importation by APHIS in our 
regulations, and our regulations do not make the distinction between 
(1) commodities that have been evaluated and prohibited, (2) 
commodities that are not currently allowed importation but that are 
undergoing risk evaluation, and (3) commodities that are not allowed 
importation and for which no request for risk evaluation exists. We 
recognize that our regulatory terminology is not the same as that used 
in the SPS Agreement; however, regardless of the semantics, APHIS only 
allows new imports of fruits and vegetables pending completion of some 
form of risk analysis that enables us to determine that the pest risks 
posed by the commodity are known, and that the risks can and will be 
mitigated. We believe that this policy is consistent with the 
provisions of the SPS Agreement.
    Issue: APHIS should provide a target timeline for the processing of 
an import request at the time the request is made.
    Response: It is not possible for APHIS to provide timelines, as 
there are far too many variables that can affect the amount of time it 
takes to approve a new import. Some data take longer to get or generate 
than others, and limitations on resources may affect how quickly APHIS 
is able to generate documents. If asked, APHIS will inform an exporter 
about the status of a particular risk assessment.
    Issue: The requirement that the national plant protection 
organization (NPPO) of the exporting country provide the requested 
information is not in line with international agreements and may delay 
the obtaining of the information. Furthermore, the required information 
may be better provided by other sources, such as research institutions 
or growers associations based in the country of origin.
    Response: The information does not have to originate with the NPPO, 
but it should be provided through the NPPO to ensure its official 
status and to be sure that both APHIS and the exporting country's NPPO 
have the same information. It is essential for the exporting country's 
NPPO to be actively involved because it will be responsible for 
implementation of export certification. We note that Article IV of the 
International Plant Protection Convention (IPPC) lists the 
responsibilities of an NPPO, and that these include surveillance of 
cultivated and wild plants ``with the object of reporting the 
occurrence, outbreak, and spread of pests'' and the conduct of pest 
risk analyses. Articles VII.2i and j of the IPPC also refer to an 
NPPO's responsibility to maintain pest lists, conduct surveillance, and 
make the results of surveillance available to other contracting 
parties.
    Therefore, for the reasons given in the proposed rule and in this 
document, we are adopting the proposed rule as a final rule, with the 
changes discussed in this document.

Executive Order 12866 and Regulatory Flexibility Act

    This rule has been reviewed under Executive Order 12866. The rule 
has been determined to be significant for the purposes of Executive 
Order 12866 and, therefore, has been reviewed by the Office of 
Management and Budget.

[[Page 30566]]

    We have prepared an economic analysis for this rule. The economic 
analysis provides a cost-benefit analysis as required by Executive 
Order 12866 and an analysis of the potential economic effects of this 
final rule on small entities as required by the Regulatory Flexibility 
Act. The economic analysis is set out below.
    Under the Plant Protection Act (7 U.S.C. 7701 et seq.), the 
Secretary of Agriculture is authorized to regulate the importation of 
plants, plant products, and other articles to prevent the introduction 
of injurious plant pests and noxious weeds.
    This rule will require that requests to amend the regulations 
regarding imported plants, plant parts, or plant products be 
accompanied by the basic information necessary for APHIS to properly 
consider such requests. Receipt of necessary information at the time a 
request to import a currently prohibited commodity is made will help to 
shorten our process for considering and responding to such requests by 
minimizing delays in the preparation of risk assessments and other 
required analyses. Reducing delays in our consideration of import 
requests will help enhance the standing of the United States as a 
responsive trading partner.

Commodities in 7 CFR Part 319 Potentially Affected by the Regulations

     Fruits and Vegetables.
     Cotton.
     Logs, lumber.
     Nursery Stock (planted in media).
     Sugarcane.
     Corn, Rice, Wheat, Coffee.
     Packing Material.
     Cut Flowers.

Alternatives Considered

    Two alternatives to this rule were considered. The first 
alternative was to do nothing. This alternative was rejected because 
the increased volume of import requests and the corresponding increase 
in the number of risk assessments to be prepared necessitate a 
mechanism for facilitating the import request process. The second 
alternative considered was to limit the rule to fresh fruits and 
vegetables only. Excluding other plants and plant products from this 
rule was not seen as the most effective regulatory approach, given the 
growing volume and value of trade in commodities such as grains, 
cotton, nursery stock, and cut flowers.

Benefits of the Rule

Trade Benefits
    Establishing a more efficient process for the consideration of 
import requests will benefit trading partners seeking to sell their 
products in U.S. markets by allowing them to bring products to market 
in the United States in a more timely fashion in those cases where our 
analyses support a change in existing prohibitions or restrictions. 
This rule will have a positive effect on U.S. consumers who benefit 
from increased variety of imported products available in domestic 
markets and from increased competition and lower prices in affected 
markets. Enhancing the standing of the United States as a responsive 
trading partner will help to foster a favorable trade climate with 
other countries, which can be expected to generally benefit U.S. 
exporters of fruits, vegetables, and other commodities.
Efficiency Gains
    A related benefit of this rule for U.S. interests is internal APHIS 
efficiency and consistency gains related to processing import requests. 
Collecting data necessary for risk assessments requires time, which 
delays processing of import requests.
    For the past several years, APHIS has conducted approximately 100 
risk assessments associated with import requests per year. Of those 
risk assessments, 90 percent are routine and 10 percent are complex. 
Examples of recent complex assessments relate to the importation of 
citrus from Argentina, clementines from Spain, and citrus from Uruguay. 
Once initiated, complex risk assessments typically require 2 to 3 
months for data collection by APHIS, plus trips to the country of 
origin; data collection for routine risk assessments usually requires 
30 days or less.
    Submission of basic information with the import request will 
substantially decrease the amount of time required for data collection 
for both routine and complex risk assessments and the need for 
international travel to collect information. Providing information at 
the time an import request is made will require some expenditure of 
time and effort by the applicant. However, assembling data is expected 
to require substantially less time for the applicant than for APHIS 
employees, especially if the applicant is in the country of origin. 
Applicants in the country of origin should have knowledge of the 
commodity they wish to export and access to the required data.
    Even when the risk analysis is not complex, or in cases where a 
risk analysis may not be required, the information we will require can 
be used to complete other analyses or documentation required by certain 
U.S. statutes, such as the Regulatory Flexibility Act, the National 
Environmental Policy Act, and the Endangered Species Act, to support 
changes in our regulations. Delays or problems with any of these 
analyses can affect the timely processing of import requests.

Costs of the Regulations

    The regulations will require that the NPPOs of foreign countries 
provide specific information in support of import requests. This will 
require an additional expenditure of time and effort on the part of 
potential exporters and the exporting country's NPPO, but APHIS does 
not expect major adjustment problems for those entities. Required 
information about commodities should be known to applicants and readily 
available.
    APHIS believes that the benefits of this rule (streamlining the 
process for evaluating import requests and reducing costs to APHIS) 
outweigh the costs to applicants associated with gathering the basic 
information required by this rule.

Regulatory Flexibility Analysis

    As a part of the rulemaking process, APHIS evaluates whether its 
regulations are likely to have a significant economic impact on a 
substantial number of small entities. It is unclear whether or to what 
extent the costs associated with meeting the data requirements of the 
regulations will be passed on to U.S. brokers/shippers of plants and 
plant products. More than 11,406 brokers/shippers of plants and plant 
products would be considered small entities under the Small Business 
Administration's (SBA) criteria, but we do not expect that the data 
requirements will have a significant impact on them.
    Under the SBA's criteria, an import/export merchant is classified 
as a small entity if it has 100 or fewer employees.\1\ In all cases, 
these entities can be expected to be affected only to the extent that 
foreign producers or exporters pass on their additional costs 
associated with assembling the data required for the original import 
request, which are expected to be minimal.
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    \1\ North American Industrial Classification System code 424480, 
Fresh Fruit and Vegetable Merchant Wholesalers.
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    According to the most recent information available from the SBA's 
Office of Advocacy, a total of 5,403 firms comprised the ``Fresh Fruit 
and Vegetable Merchant Wholesalers'' category in 1999.\2\ Seventy-eight 
percent of these firms (4,227) employed 20 or fewer individuals, and 99 
percent of the firms had 500 or fewer employees. Clearly, the majority 
of fruit and

[[Page 30567]]

vegetable wholesalers are small entities, having 100 or fewer 
employees. Other types of wholesalers potentially affected by the 
regulations (wholesalers of cut flowers and nursery stock, grain and 
beans, and other farm product raw materials) demonstrate similar 
demographic profiles, with the majority of firms in each industry 
considered small under SBA's criteria. Even though the majority of 
potentially affected wholesalers have 100 or fewer employees, and will 
thus be classified as small entities, the regulations are not expected 
to have a significant economic impact on them.
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    \2\ See http://www.sba.gov/advo/stats/us99_n6.pdf.
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    Under these circumstances, the Administrator of the Animal and 
Plant Health Inspection Service has determined that this action will 
not have a significant economic impact on a substantial number of small 
entities.

Executive Order 12988

    This final rule has been reviewed under Executive Order 12988, 
Civil Justice Reform. This rule: (1) Preempts all State and local laws 
and regulations that are inconsistent with this rule; (2) has no 
retroactive effect; and (3) does not require administrative proceedings 
before parties may file suit in court challenging this rule.

Paperwork Reduction Act

    In accordance with Paperwork Reduction Act of 1995 (44 U.S.C. 3501 
et seq.), the information collection or recordkeeping requirements 
included in this rule have been approved by the Office of Management 
and Budget (OMB) under OMB control number 0579-0261.

Government Paperwork Elimination Act Compliance

    The Animal and Plant Health Inspection Service is committed to 
compliance with the Government Paperwork Elimination Act (GPEA), which 
requires Government agencies in general to provide the public the 
option of submitting information or transacting business electronically 
to the maximum extent possible. For information pertinent to GPEA 
compliance related to this rule, please contact Mrs. Celeste Sickles, 
APHIS' Information Collection Coordinator, at (301) 734-7477.

List of Subjects in 7 CFR Part 319

    Coffee, Cotton, Fruits, Imports, Logs, Nursery stock, Plant 
diseases and pests, Quarantine, Reporting and recordkeeping 
requirements, Rice, Vegetables.


0
Accordingly, we are amending 7 CFR part 319 as follows:

PART 319--FOREIGN QUARANTINE NOTICES

0
1. The authority citation for part 319 continues to read as follows:

    Authority: 7 U.S.C. 450, 7701-7772, and 7781-7786; 21 U.S.C. 136 
and 136a; 7 CFR 2.22, 2.80, and 371.3.

0
2. A new ``Subpart-Requests To Amend The Regulations'' (Sec.  319.5) is 
added to read as follows:

Subpart--Requests To Amend The Regulations


Sec.  319.5  Requirements for submitting requests to change the 
regulations in 7 CFR part 319.

    (a) Definitions.
    Commodity. A plant, plant product, or other agricultural product 
being moved for trade or other purpose.
    (b) Procedures for submitting requests and supporting information. 
Persons who request changes to the import regulations contained in this 
part and who wish to import plants, plant parts, or plant products that 
are not allowed importation under the conditions of this part must file 
a request with the Animal and Plant Health Inspection Service (APHIS) 
in order for APHIS to consider whether the new commodity can be safely 
imported into the United States. The initial request can be formal 
(e.g., a letter) or informal (e.g., made during a bilateral discussion 
between the United States and another country), and can be made by any 
person. Upon APHIS confirmation that granting a person's request would 
require amendments to the regulations in this part, the national plant 
protection organization of the country from which the commodity would 
be exported must provide APHIS with the information listed in paragraph 
(d) of this section before APHIS can proceed with its consideration of 
the request; requests that are not supported with this information in a 
timely manner will be considered incomplete and APHIS may not take 
further action on such requests until all required information is 
submitted.
    (c) Addresses. The national plant protection organization of the 
country from which commodities would be exported must submit the 
information listed in paragraph (d) of this section to: Commodity 
Import Analysis and Operations, PPQ, APHIS, 4700 River Road Unit 140, 
Riverdale, MD 20737.
    (d) Information. The following information must be provided to 
APHIS in order for APHIS to consider a request to change the 
regulations in part 319:
    (1) Information about the party submitting the request. The 
address, telephone and fax numbers, and e-mail addresses of the 
national plant protection organization of the country from which 
commodities would be exported; or, for requests that address a multi-
country region, the address, telephone and fax numbers, and e-mail 
addresses of the exporting countries' national and regional plant 
protection plant protection organizations.
    (2) Information about the commodity proposed for importation into 
the United States. (i) A description and/or map of the specific 
location(s) of the areas in the exporting country where the plants, 
plant parts, or plant products are produced;
    (ii) The scientific name (including genus, species, and author 
names), synonyms, and taxonomic classification of the commodity;
    (iii) Identification of the particular plant or plant part (i.e., 
fruit, leaf, root, entire plant, etc.) and any associated plant part 
proposed for importation into the United States;
    (iv) The proposed end use of the imported commodity (e.g., 
propagation, consumption, milling, decorative, processing, etc.); and
    (v) The months of the year when the commodity would be produced, 
harvested, and exported.
    (3) Shipping information: (i) Detailed information as to the 
projected quantity and weight/Volume of the proposed importation, 
broken down according to varieties, where applicable, and;
    (ii) Method of shipping in international commerce and under what 
conditions, including type of conveyance, and type, size, and capacity 
of packing boxes and/or shipping containers.
    (4) Description of pests and diseases associated with the commodity 
\1\ (i) Scientific name (including genus, species, and author names) 
and taxonomic classification of arthropods, fungi, bacteria, nematodes, 
virus, viroids, mollusks, phytoplasmas, spiroplasmas, etc., attacking 
the crop;
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    \1\ When a change is being sought to the conditions governing 
the importation of a commodity that is already authorized for 
importation into the United States, an update to or confirmation of 
previously submitted pest and disease information, rather than a 
new, complete submission of that information, may be appropriate. 
Persons seeking such a change may contact APHIS for a determination 
as to whether an update will be appropriate in a particular case.
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    (ii) Plant part attacked by each pest, pest life stages associated 
with each plant part attacked, and location of pest (in, on, or with 
commodity); and
    (iii) References.
    (5) Current strategies for risk mitigation or management. (i) 
Overview of agronomic or horticultural

[[Page 30568]]

management practices used in production of the commodity, including 
methods of pest risk mitigation or control programs; and
    (ii) Identification of parties responsible for pest management and 
control.
    (e) Additional information. None of the additional information 
listed in this paragraph need be provided at the same time as 
information required under paragraphs (a) through (d) of this section; 
it is required only upon request by APHIS. If APHIS determines that 
additional information is required in order to complete a pest risk 
analysis in accordance with international standards for pest risk 
analysis, we will notify the party submitting the request in writing 
what specific additional information is required. If this information 
is not provided, and is not available to APHIS from other sources, a 
request may be considered incomplete and APHIS may be unable to take 
further action on the request until the necessary additional 
information is submitted. The additional information may include one or 
more of the following types of information:
    (1) Contact information: Address, phone and fax numbers, and/or e-
mail address for local experts (e.g., academicians, researchers, 
extension agents) most familiar with crop production, entomology, plant 
pathology, and other relevant characteristics of the commodity proposed 
for importation.
    (2) Additional information about the commodity: (i) Common name(s) 
in English and the language(s) of the exporting country;
    (ii) Cultivar, variety, or group description of the commodity;
    (iii) Stage of maturity at which the crop is harvested and the 
method of harvest;
    (iv) Indication of whether the crop is grown from certified seed or 
nursery stock, if applicable;
    (v) If grown from certified seed or stock, indication of the origin 
of the stock or seed (country, State); and
    (vi) Color photographs of plant, plant part, or plant product 
itself.
    (3) Information about the area where the commodity is grown: (i) 
Unique characteristics of the production area in terms of pests or 
diseases;
    (ii) Maps of the production regions, pest-free areas, etc.;
    (iii) Length of time the commodity has been grown in the production 
area;
    (iv) Status of growth of production area (i.e., acreage expanding 
or stable); and
    (v) Physical and climatological description of the growing area.
    (4) Information about post-harvest transit and processing: (i) 
Complete description of the post-harvest processing methods used; and
    (ii) Description of the movement of the commodity from the field to 
processing to exporting port (e.g., method of conveyance, shipping 
containers, transit routes, especially through different pest risk 
areas).
    (5) Shipping methods: (i) Photographs of the boxes and containers 
used to transport the commodity; and
    (ii) Identification of port(s) of export and import and expected 
months (seasons) of shipment, including intermediate ports-of-call and 
time at intermediate ports-of-call, if applicable.
    (6) Additional description of all pests and diseases associated 
with the commodity to be imported: (i) Common name(s) of the pest in 
English and local language(s);
    (ii) Geographic distribution of the pest in the country, if it is a 
quarantine pest and it follows the pathway;
    (iii) Period of attack (e.g., attacks young fruit beginning 
immediately after blooming) and records of pest incidence (e.g., 
percentage of infested plants or infested fruit) over time (e.g., 
during the different phenological stages of the crops and/or times of 
the year);
    (iv) Economic losses associated with pests of concern in the 
country;
    (v) Pest biology or disease etiology or epidemiology; and
    (vi) Photocopies of literature cited in support of the information 
above.
    (7) Current strategies for risk mitigation or management: (i) 
Description of pre-harvest pest management practices (including target 
pests, treatments [e.g., pesticides], or other control methods) as well 
as evidence of efficacy of pest management treatments and other control 
methods;
    (ii) Efficacy of post-harvest processing treatments in pest 
control;
    (iii) Culling percentage and efficacy of culling in removing pests 
from the commodity; and
    (iv) Description of quality assurance activities, efficacy, and 
efficiency of monitoring implementation.
    (8) Existing documentation: Relevant pest risk analyses, 
environmental assessment(s), biological assessment(s), and economic 
information and analyses.
    (f) Availability of additional guidance. Information related to the 
processing of requests to change the import regulations contained in 
this part may be found on the APHIS Web site at http://www.aphis.usda.gov/ppq/pra/.

(Approved by the Office of Management and Budget under control 
number 0579-0261)

    Done in Washington, DC, this 23rd day of May 2006.
Charles D. Lambert,
Acting Under Secretary for Marketing and Regulatory Programs.
 [FR Doc. E6-8238 Filed 5-26-06; 8:45 am]
BILLING CODE 3410-34-P