[Federal Register Volume 69, Number 208 (Thursday, October 28, 2004)]
[Proposed Rules]
[Pages 62823-62829]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-24150]


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Proposed Rules
                                                Federal Register
________________________________________________________________________

This section of the FEDERAL REGISTER contains notices to the public of 
the proposed issuance of rules and regulations. The purpose of these 
notices is to give interested persons an opportunity to participate in 
the rule making prior to the adoption of the final rules.

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Federal Register / Vol. 69, No. 208 / Thursday, October 28, 2004 / 
Proposed Rules

[[Page 62823]]



DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

7 CFR Part 319

[Docket No. 02-132-1]
RIN 0579-AB83


Requirements for Requests To Amend Import Regulations

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Proposed rule.

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SUMMARY: We are proposing to establish regulations governing the 
submission of requests for changes in our regulations that restrict the 
importation of plants, plant parts, and plant products. We are 
proposing 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. We expect 
that adoption of this proposal would 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 the 
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: We will consider all comments that we receive on or before 
December 27, 2004.

ADDRESSES: You may submit comments by any of the following methods:
    <bullet> Postal Mail/Commercial Delivery: Please send four copies 
of your comment (an original and three copies) to Docket No. 02-132-1, 
Regulatory Analysis and Development, PPD, APHIS, Station 3C71, 4700 
River Road Unit 118, Riverdale, MD 20737-1238. Please state that your 
comment refers to Docket No. 02-132-1.
    <bullet> E-mail: Address your comment to 
<a href="/cdn-cgi/l/email-protection#21534446544d4055484e4f526140514948520f545245400f464e57"><span class="__cf_email__" data-cfemail="beccdbd9cbd2dfcad7d1d0cdfedfced6d7cd90cbcddadf90d9d1c8">[email protected]</span></a>. Your comment must be contained in the body 
of your message; do not send attached files. Please include your name 
and address in your message and ``Docket No. 02-132-1'' on the subject 
line.
    <bullet> Agency Web Site: Go to http://www.aphis.usda.gov/ppd/rad/cominst.html for a form you can use to submit an e-mail comment through 
the APHIS Web site.
    <bullet> Federal eRulemaking Portal: Go to http://www.regulations.gov and follow the instructions for locating this 
docket and submitting comments.
    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: You may view APHIS documents published in the 
Federal Register and related information, including the names of groups 
and individuals who have commented on APHIS dockets, on the Internet at 
http://www.aphis.usda.gov/ppd/rad/webrepor.html.

FOR FURTHER INFORMATION CONTACT: For information related to risk 
analyses, 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.
    For information related to environmental analyses, contact Mr. Carl 
Bausch, Chief, Environmental Services, PPD, APHIS, 4700 River Road Unit 
149, Riverdale, MD 20737-1237; (301) 734-8963.
    For information related to economic analyses, contact Mr. 
Christopher Klocek, Economist, Policy Analysis and Development, PPD, 
APHIS, 4700 River Road Unit 119, Riverdale, MD 20737-1238; (301) 734-
8667.

SUPPLEMENTARY INFORMATION:

Background

    The regulations contained in 7 CFR part 319 (referred to below as 
the part 319 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. 7701-7772). 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 allowed importation under the 
regulations.
    On June 19, 2001, APHIS published a notice in the Federal Register 
(66 FR 32923-32928, Docket No. 00-082-1) which described procedures and 
standards employed by APHIS in its consideration of such requests. As 
part of that document, we requested that persons seeking to import a 
new commodity \1\ for which a risk analysis is required submit specific 
information in support of their request in order to expedite APHIS's 
consideration of the request. In the notice, we explained that if APHIS 
is provided with certain information regarding the commodity, its 
country of origin, and the pests associated with it, then we would be 
better able to consider the request and conduct the risk analysis in a 
timely fashion. We also explained that, after reviewing the submitted 
information, we may request any other associated information that may 
be needed to complete a risk analysis.
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    \1\ For the purposes of this document, the term ``commodity'' 
means a plant, plant product, or other agricultural product being 
moved for trade or other purpose.
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    In this document, we are proposing to establish regulations 
governing the submission of requests to change the part 319 import 
regulations. We are proposing this action because, despite our 
publication of the June 2001 notice 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. 
We expect that adoption of this proposal would 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 the

[[Page 62824]]

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. Without this 
information, we are unable to effectively consider such requests.
    The information we are proposing to require is the same type of 
information that we are required to provide to other countries as they 
evaluate commodities that we wish to export. Furthermore, the 
provisions of this proposal are consistent with country obligations 
under the International Plant Protection Convention (IPPC), to which 
the United States is a signatory.

Process for Considering Requests

    When APHIS is requested to allow the importation of a commodity, 
APHIS first reviews the regulations to determine whether the commodity 
is enterable under existing regulations. If the commodity is enterable, 
APHIS may issue a permit for the importation of the commodity, subject 
to applicable regulations in part 319. Such cases would not require the 
submission of information as proposed in this document.
    However, if the commodity is not yet authorized for importation 
under existing regulations, APHIS would have to undertake rulemaking to 
change the commodity's regulatory status before the commodity could be 
imported. The first step in this process involves determining whether 
it is necessary to conduct a risk analysis to analyze the pest risk 
associated with the importation of the commodity. When APHIS determines 
whether a pest risk analysis is necessary, we formally advise the 
requestor of that finding.
    Regardless of whether or not a pest risk analysis is necessary, 
APHIS needs certain basic information (described in detail under the 
heading Required Information) to begin considering the request, and, in 
some cases, may require additional information (described under the 
heading Additional Information) to complete our evaluation. If a risk 
analysis is required,\2\ the information is needed to conduct the 
analysis in accordance with the International Standard for 
Phytosanitary Measures (ISPM) No. 11, ``Pest Risk Analysis for 
Quarantine Pests,'' and its supplements, set by the IPPC. The 
completion of a risk analysis may be necessary to inform the Secretary 
as she makes her determination to allow or prohibit the importation of 
a commodity in accordance with the authority conferred on her by the 
Plant Protection Act.
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    \2\ Note: The results of a risk analysis may or may not support 
the proposed action.
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    Even if a risk analysis is not required to analyze the pest risk 
associated with the importation of the commodity,\3\ the majority of 
the information listed under the heading Required Information is still 
needed for the purposes of other analyses that are designed to satisfy 
the requirements of certain U.S. statutes.\4\ The following is a list 
of the U.S. statutes that most often have effects on the process of 
consideration of requests. This list is not exhaustive, but the 
analyses they require are the ones that depend most on certain types of 
information that are described in this document.
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    \3\ There are few cases where completion of risk analysis of 
some kind would not be required. The most obvious case would be if a 
risk analysis already exists.
    \4\ The only Required Information that may be superfluous for 
these analyses is information about associated pests and current 
risk mitigation strategies.
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    <bullet> The Regulatory Flexibility Act (5 U.S.C. 601 et seq.) 
requires Federal agencies to consider the effect of proposed rules on 
small businesses, nonprofit organizations, and government 
jurisdictions. In order to comply with the requirements of the 
Regulatory Flexibility Act, for each rulemaking action, APHIS conducts 
an analysis on the economic effects the rule may have on small 
entities.
    <bullet> Crop Insurance Reform and Department of Agriculture 
Reorganization Act of 1994 (Pub. L. 103-354) requires rules classified 
as ``major'' (having an annual impact on the economy of the United 
States of $100 million in 1994 dollars and whose primary purpose is to 
regulate issues of human health, human safety, or the environment) to 
be based on a thorough analysis that makes clear the nature of the risk 
posed by the action, alternative ways of reducing the risk, the 
reasoning that justifies the rule, and a comparison of the likely costs 
and benefits of reducing the risk.
    <bullet> The National Environmental Policy Act (NEPA), as amended 
(42 U.S.C. 4321 et seq.) and the Council on Environmental Quality's 
regulations for implementing the procedural provisions of NEPA require 
Federal agencies to consider the effects of their actions on the 
natural environment and identify alternatives to proposed actions. 
APHIS typically prepares environmental assessments, and in some cases, 
environmental impact statements, to evaluate the environmental effects 
of new imports of plants, plant parts, and plant products.
    <bullet> The Endangered Species Act, as amended (16 U.S.C. 1531 et 
seq.) requires that Federal agencies ensure that their actions do not 
jeopardize the continued existence of species that are listed as 
threatened or endangered or adversely modify critical habitat. In 
certain cases, APHIS is required to enter into consultations with the 
U.S. Fish and Wildlife Service to provide evidence that our actions 
would not adversely affect threatened or endangered species or their 
critical habitats.
    Risk analyses and other analyses required under the statutes 
described above are integral parts of the body of documentation that 
are required by law to support changes in our regulations. The findings 
of these analyses form the foundation of the rational basis for 
rulemaking required under the Administrative Procedure Act. Problems 
(e.g., a shortage of data) with any one of these analyses can have 
effects on the timely processing of a request. To facilitate the 
completion of these analyses, we have identified the basic information 
that is required in any case for us to begin conducting a risk analysis 
and other analyses required by law. We have also identified additional 
information that may become necessary at some stage of the processing 
of the request, but that may not be required in all, or even most, 
cases. In this document, we are proposing to establish regulations to 
clarify the process for evaluating requests and the information we 
require to consider such requests.

The Proposed Regulations

    Under the proposed regulations, which would be located in a new 
``Subpart--Requests To Amend the Regulations'' (7 CFR 319.5), persons 
interested in the importation into the United States of commodities 
that have not been evaluated for entry into the United States and that 
are not specifically approved for importation into the United States 
under part 319 would be required to file a request with APHIS. The 
initial request could be formal (i.e., a letter from the government of 
the exporting country) or informal (i.e., a phone call to an import 
specialist from a foreign producer or prospective importer), and could 
be made by any person. Upon APHIS's confirmation that granting the 
person's request would necessitate revisions to the regulations in part 
319 (regardless of whether a risk analysis is determined to be 
necessary), APHIS would notify the person that, prior to consideration 
of the request, the national plant protection organization of the 
country from which the plants, plant parts, or plant products would be

[[Page 62825]]

exported would be required to provide APHIS with the information 
described in proposed Sec.  319.5(d). Requests that do not contain this 
information will be considered incomplete, and APHIS may not take 
further action on such requests until all required information is 
submitted. Under Sec.  319.5(c) of the proposed regulations, this 
information would be required to be submitted to a designated APHIS 
contact point.

Required Information

    The regulations in Sec.  319.5(d) would require the following 
information to be provided to APHIS:
    Information about the party submitting the request:
    <bullet> For requests that address imports from a single country, 
the address, telephone and fax numbers, and e-mail addresses of the 
national plant protection organization of the country from which the 
commodity would be exported, or
    <bullet> 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 
organizations.
    Information about the commodity proposed for importation into the 
United States:
    <bullet> A description and/or map of the specific location(s) of 
the areas in the exporting country where the commodity is produced,
    <bullet> The scientific name (including genus, species, and author 
names), synonyms, and taxonomic classification of the commodity,
    <bullet> 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,
    <bullet> The proposed end use of the imported commodity (e.g., 
propagation, consumption, milling, decorative, processing, etc.), and
    <bullet> The months of the year when the commodity would be 
produced, harvested, and exported.
    Shipping information:
    <bullet> Detailed information as to the projected quantity and 
weight/volume of the proposed importation, broken down according to 
varieties where applicable, and
    <bullet> 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.
    Description of all pests and diseases associated with the commodity 
proposed for exportation to the United States:
    <bullet> 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,
    <bullet> 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
    <bullet> References.
    Current strategies for risk mitigation or management:
    <bullet> Overview \5\ of agronomic or horticultural management 
practices used in the production of the commodity, including methods of 
pest risk mitigation or control programs, and
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    \5\ We specifically welcome comments as to the exact type and 
amount of information that can or should be submitted in support of 
this requirement.
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    <bullet> Identification of parties responsible for pest management 
and control.

Additional Information

    In addition to the information described above, in some cases, 
APHIS may require additional information to effectively consider 
requests to amend the part 319 regulations. We are requesting public 
comment as to whether some or all of this additional information should 
be required to be submitted with the information described above, 
whether some or all of the information should be considered 
``optional,'' or whether APHIS should require submission of some or all 
of the information only if we deem it necessary during the course of 
our consideration of a request. We wish to make it clear that it is 
very much in the interest of the exporting country's national plant 
protection organization to provide as much of the following information 
as possible in order to facilitate the timely consideration of a 
request. If APHIS needs this information but does not receive it from 
the national plant protection organization of the exporting country, we 
must seek the information from available sources or take other 
appropriate action on the request. Accordingly, the consideration of 
requests may be delayed substantially or even denied.
    Contact information:
    Address, phone and fax numbers, and/or e-mail 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.
    Additional information about the commodity:
    <bullet> Common name(s) in English and in the language(s) of the 
exporting country,
    <bullet> Cultivar, variety, or group description of the commodity,
    <bullet> Stage of maturity at which crop is harvested and method of 
harvest,
    <bullet> Indication of whether crop is grown from certified seed or 
nursery stock, if applicable,
    <bullet> If grown from certified seed or stock, indication of the 
origin of the stock or seed (country, State), and
    <bullet> Color photographs of plant, plant part, or plant product 
itself.
    Information about the area where the commodity is grown:
    <bullet> Unique characteristics of the production area in terms of 
pests or diseases,
    <bullet> Maps of the production regions, pest free areas, etc.,
    <bullet> Length of time commodity has been grown in production 
area,
    <bullet> Status of growth of production area (i.e., acreage 
expanding or stable), and
    <bullet> Physical and climatological description of the growing 
area.
    Information about post-harvest transit and processing:
    <bullet> Complete description of the post-harvest processing 
methods used, and
    <bullet> Description of the movement of the commodity from field to 
processing to exporting port (e.g., method of conveyance, shipping 
containers, transit routes, especially through different pest risk 
areas).
    Shipping methods and volume of exports:
    <bullet> Photographs of the boxes and containers used to transport 
the commodity, and
    <bullet> 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.
    Additional description of all pests and diseases associated with 
the commodity to be imported:
    <bullet> Common name(s) of the pest in English or local 
language(s),
    <bullet> Geographic distribution of the pest in the country, if a 
quarantine pest and follows the pathway,
    <bullet> 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),
    <bullet> Economic losses associated with pests of concern in the 
country,
    <bullet> Pest biology or disease etiology or epidemiology, and
    <bullet> Photocopies of literature cited in support of the 
information above.
    Current strategies for risk mitigation or manageament:
    <bullet> Description of pre-harvest pest management practices 
(including target pests, treatments [e.g., pesticides], or

[[Page 62826]]

other control methods) as well as evidence of efficacy of pest 
management treatments and other control methods,
    <bullet> Efficacy of post-harvest processing treatments in pest 
control,
    <bullet> Culling percentage and efficacy of culling in removing 
pests from the commodity, and
    <bullet> Description of quality assurance activities, efficacy and 
efficiency of monitoring implementation.
    Existing documentation:
    <bullet> Relevant pest risk analyses, environmental assessment(s), 
biological assessment(s), and economic information and analyses.

Availability of Guidance on the Internet

    In conjunction with this rule, we would post information related to 
this subject on the APHIS Internet site. The site would include a 
document that clearly explains the information required to be submitted 
at the time of the import request and the additional desirable 
information described in this document, background information on the 
rulemaking process and the analytical requirements APHIS must meet as 
it proposes and adopts revisions to its import regulations, and 
documents intended to facilitate the preparation of the information 
described in this document prior to submission to APHIS. We would 
provide a link for that Web site in our final rule.

Executive Order 12866 and Regulatory Flexibility Act

    This proposed 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.
    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. 7701-7772), 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.
    This proposed rule would 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 (previously 
described in this docket) at the time a request to import a currently 
prohibited commodity is made will streamline the process for 
considering the request by minimizing delays and backlogs in conducting 
risk assessments and other required analyses. Streamlining the process 
will help facilitate trade of both imported and exported plants and 
plant products covered by 7 CFR part 319, and help maintain good 
relations between the United States and its trading partners.

Commodities in 7 CFR Part 319 Potentially Affected by the Proposed 
Regulations

    <bullet> Fruits and Vegetables
    <bullet> Cotton
    <bullet> Logs, lumber
    <bullet> Nursery Stock (planted in media)
    <bullet> Sugarcane
    <bullet> Corn, Rice, Wheat, Coffee
    <bullet> Packing Material
    <bullet> Cut Flowers
    Streamlining the process for requesting changes to the import 
regulations 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. This proposed rule, if 
adopted, would 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. Maintaining good trade relations ensures that U.S. exports of 
fruits, vegetables, and other commodities would continue to flow freely 
into markets around the world. This would benefit U.S. exporters. 
Uncertainty and delays can be costly for U.S. exporters of perishable 
commodities, whose window for shipping fresh produce and live plants is 
brief. Some U.S. brokers/shippers who handle imported plants and plant 
products may be affected, but costs to them should be negligible.

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 growing backlog of risk 
assessments 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 plant and plant parts 
from this rule was not seen as the most effective regulatory approach, 
given the growing volume and value of reciprocal trade in commodities 
such as grains, cotton, nursery stock, and cut flowers (see table 1).

Benefits of the Proposed Rule

Trade Benefits
    An important benefit of expediting the risk assessment process is 
the continued smooth functioning of trade, particularly with countries 
where there is significant reciprocal trade in plants and plant 
products. U.S. exports of plants, plant parts, and plant products are 
extensive. For example, the United States exported roughly $4.26 
billion in plants, plant parts, and plant products to major trading 
partners Mexico, Taiwan, and China in 2003. As the table below 
suggests, given the volume of trade in plant and plant products, delays 
by trading partners in processing U.S. import requests could be costly 
for U.S. exporters.

                               Table 1.--2003 U.S. Exports of Selected Commodities
----------------------------------------------------------------------------------------------------------------
                                                                    Value of exports  (in millions of dollars)
Commodity harmonized tariff codes      Commodity description     -----------------------------------------------
               (HS)                                                   Mexico          Taiwan           China
----------------------------------------------------------------------------------------------------------------
5201, 5203.......................  Cotton.......................        $427.658        $117.153        $733.168
4407, 4403, 4406.................  Lumber and logs..............         139.405          60.769         190.467
4415.............................  Pallets, packing material....          13.463           0.123           0.168
08...............................  Edible fruits and nuts.......         256.559         134.824          50.579
07...............................  Vegetables...................         110.330          27.444           9.553
1701.............................  Sugarcane....................           0.785           0.034           0.001
0603.............................  Cut flowers..................           1.132               0           0.021
0601, 0602.......................  Live plants, grasses, bulbs..          21.215           0.071           0.594
0604.............................  Tubers.......................  ..............  ..............  ..............

[[Page 62827]]

 
1005.............................  Corn.........................         689.611         513.785           0.658
1006.............................  Rice.........................         140.263          34.078           0.079
1001.............................  Wheat........................         402.083         136.371          35.262
0901.............................  Coffee.......................           1.966           0.727           0.391
                                                                 -----------------
    Total........................  .............................       2,204.470       1,025.379       1,020.941
----------------------------------------------------------------------------------------------------------------
 Source: http://www.fas.usda.gov/ustrdscripts/USReport.exe. Trade data are reported by commodity tariff code,
  also known as harmonized tariff schedule (HS).

Efficiency Gains

    A related benefit of this proposed 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. 
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 are proposing to 
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 Proposed Regulations

    The proposed regulations would require that the national plant 
protection organizations of foreign countries provide specific 
information in support of import requests. This would require an 
additional expenditure of time and effort on the part of potential 
exporters and the exporting country's national plant protection 
organization, but APHIS does not expect major adjustment problems for 
those persons. Required information about commodities should be known 
to applicants and readily available.
    Many foreign firms use U.S. brokers in order to facilitate the 
movement of consignments into the United States. The broker's primary 
role is to make arrangements and obtain appropriate documentation for 
the import and export of goods. The task of assembling required data 
could fall to U.S. brokers in some cases, but any adjustment should be 
short-lived, as importers, brokers, and governments of exporting 
countries work toward the common goal of expanded commerce.
    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 
proposed regulations are likely to have a significant economic impact 
on a substantial number of small entities.\6\ It is unclear whether or 
to what extent the data requirements of the proposed regulations would 
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 proposed data 
requirements would have a significant impact on them.
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    \6\ ``Guide to the Regulatory Flexibility Act.'' Small Business 
Administration, Office of Advocacy, Washington, DC, May 1996.
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    Under the SBA's criteria, an import/export merchant is classified 
as a small entity if it has 100 or fewer employees.\7\ In all cases, 
the impact would only be as a result of an entity's involvement in 
assembling data required for the import request.
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    \7\ North American Industrial Classification System (NAICS) 
424480, Fresh Fruit and Vegtable 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.\8\ 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 vegetable wholesalers are small entities, having 100 or 
fewer employees. Other types of wholesalers potentially affected by the 
proposed 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 the 
industry considered small under SBA's criteria. Even though the 
majority of potentially affected wholesalers have 100 or fewer 
employees, and would thus be classified as small entities, the proposed 
regulations are not expected to have a significant economic impact on 
them.
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    \8\ 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 would 
not have a significant economic impact on a substantial number of small 
entities.

Executive Order 12988

    This proposed rule has been reviewed under Executive Order 12988, 
Civil

[[Page 62828]]

Justice Reform. If this proposed rule is adopted: (1) All State and 
local laws and regulations that are inconsistent with this rule will be 
preempted; (2) no retroactive effect will be given to this rule; and 
(3) administrative proceedings will not be required before parties may 
file suit in court challenging this rule.

Paperwork Reduction Act

    In accordance with section 3507(d) of the Paperwork Reduction Act 
of 1995 (44 U.S.C. 3501 et seq.), the information collection or 
recordkeeping requirements included in this proposed rule have been 
submitted for approval to the Office of Management and Budget (OMB). 
Please send written comments to the Office of Information and 
Regulatory Affairs, OMB, Attention: Desk Officer for APHIS, Washington, 
DC 20503. Please state that your comments refer to Docket No. 02-132-1. 
Please send a copy of your comments to: (1) Docket No. 02-132-1, 
Regulatory Analysis and Development, PPD, APHIS, Station 3C71, 4700 
River Road Unit 118, Riverdale, MD 20737-1238, and (2) Clearance 
Officer, OCIO, USDA, room 404-W, 14th Street and Independence Avenue 
SW., Washington, DC 20250. A comment to OMB is best assured of having 
its full effect if OMB receives it within 30 days of publication of 
this proposed rule.
    Under this rule, persons who wish to import an agricultural 
commodity into the United States that is not currently approved for 
importation will be required to submit certain information to APHIS in 
support of their request.
    We are soliciting comments from the public (as well as affected 
agencies) concerning our proposed information collection and 
recordkeeping requirements. These comments will help us:
    (1) Evaluate whether the proposed information collection is 
necessary for the proper performance of our agency's functions, 
including whether the information will have practical utility;
    (2) Evaluate the accuracy of our estimate of the burden of the 
proposed information collection, including the validity of the 
methodology and assumptions used;
    (3) Enhance the quality, utility, and clarity of the information to 
be collected; and
    (4) Minimize the burden of the information collection on those who 
are to respond (such as through the use of appropriate automated, 
electronic, mechanical, or other technological collection techniques or 
other forms of information technology; e.g., permitting electronic 
submission of responses).
    Estimate of burden: Public reporting burden for this collection of 
information is estimated to average 2 hours per response.
    Respondents: U.S. importers, foreign producers and regulatory 
officials.
    Estimated annual number of respondents: 100.
    Estimated annual number of responses per respondent: 6.
    Estimated annual number of responses: 600.
    Estimated total annual burden on respondents: 1,200 hours. (Due to 
averaging, the total annual burden hours may not equal the product of 
the annual number of responses multiplied by the reporting burden per 
response.)
    Copies of this information collection can be obtained from Mrs. 
Celeste Sickles, APHIS' Information Collection Coordinator, at (301) 
734-7477.

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 proposed rule, please contact Mrs. Celeste 
Sickles, APHIS' Information Collection Coordinator, at (301) 734-7477.

List of Subjects in 7 CFR Part 319

    Bees, Coffee, Cotton, Fruits, Honey, Imports, Nursery Stock, Plant 
diseases and pests, Quarantine, Reporting and recordkeeping 
requirements, Rice, Vegetables.

    Accordingly, we propose to amend 7 CFR part 319 as follows:

PART 319--FOREIGN QUARANTINE NOTICES

    1. The authority citation for part 319 would continue to read as 
follows:

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

    2. A new ``Subpart--Requests To Amend the Regulations'' (Sec.  
319.5) would be 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 safely be 
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: [Address to be 
added in final rule].
    (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 
plants, plant parts, or plant products 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 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;

[[Page 62829]]

    (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. For all pests associated with the commodity proposed for 
export to the United States:
    (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;
    (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 management practices 
used in production of commodity, including methods of pest risk 
mitigation or control programs; and
    (ii) Identification of parties responsible for pest management and 
control.
    (e) 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 [Address to be added in 
final rule].

    Done in Washington, DC, this 22nd day of October 2004.
Bill Hawks,
Under Secretary for Marketing and Regulatory Programs.
[FR Doc. 04-24150 Filed 10-27-04; 8:45 am]
BILLING CODE 3410-34-P


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