[Federal Register Volume 70, Number 204 (Monday, October 24, 2005)]
[Rules and Regulations]
[Pages 61351-61362]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-21168]


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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

7 CFR Part 319

[Docket No. 03-019-3]


Certification Program for Imported Articles of Pelargonium spp. 
and Solanum spp. To Prevent Introduction of Potato Brown Rot

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Final rule.

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SUMMARY: We are adopting as a final rule, with changes, an interim rule 
that amended the regulations by establishing a certification program 
for articles of Pelargonium spp. and Solanum spp. imported from 
countries where the bacterium Ralstonia solanacearum race 3 biovar 2 
(R3B2) is known to occur. The interim rule prohibited the importation 
of articles of Pelargonium spp. and Solanum spp. from countries where 
R. solanacearum R3B2 is known to occur unless the articles are produced 
in accordance with the certification program. This final rule amends 
the regulations by modifying some of the requirements of the 
certification program to make them clearer and more flexible, by 
providing for the establishment of areas that are free of R. 
solanacearum R3B2 within countries where the bacterium is known to 
occur, and by exempting imported seeds of Pelargonium spp. and Solanum 
spp. from all requirements related to R. solanacearum R3B2. The 
requirements of the certification program are designed to ensure that 
R. solanacearum R3B2 will not be introduced into the United States 
through the importation of articles of Pelargonium spp. and Solanum 
spp. This certification program is necessary to prevent the 
introduction of this bacterial strain into the United States.

EFFECTIVE DATE: October 24, 2005.

FOR FURTHER INFORMATION CONTACT: Ms. Jeanne Van Dersal, Import 
Specialist, Phytosanitary Issues Management Team, PPQ, APHIS, 4700 
River Road Unit 140, Riverdale, MD 20737-1236; (301) 734-6653.

SUPPLEMENTARY INFORMATION: 

Background

    The regulations in 7 CFR part 319 prohibit or restrict the 
importation of certain plants and plant products into the United States 
to prevent the introduction of plant pests. The regulations contained 
in ``Subpart--Nursery Stock, Plants, Roots, Bulbs, Seeds, and Other 
Plant Products,'' Sec. Sec.  319.37 through 319.37-14 (referred to 
below as the regulations), restrict, among other things, the 
importation of living plants, plant parts, seeds, and plant cuttings 
for propagation.
    In an interim rule effective May 16, 2003, and published in the 
Federal Register on May 23, 2003 (68 FR 28115-28119, Docket No. 03-019-
1), we amended the regulations by requiring that the phytosanitary 
certificates that must accompany all articles of Pelargonium spp. and 
Solanum spp. imported into the United States contain an additional 
declaration. (Articles of Pelargonium spp. and Solanum spp. imported 
under the Canadian greenhouse-grown restricted plant program in Sec.  
319.37-4(c), which are not required to be accompanied by a 
phytosanitary certificate when they are offered for importation into 
the United States, are exempt from this requirement.) The May 2003 
interim rule was necessary because introductions of R. solanacearum 
R3B2, the bacterium that causes potato brown rot, had shown that 
articles of Pelargonium spp. and Solanum spp. can serve as vectors for 
its transmission. The additional declaration required by the May 2003 
interim rule had to state either that the articles of Pelargonium spp. 
and Solanum spp. were produced in a production site that had been 
tested and found to be free of R. solanacearum R3B2 or that R. 
solanacearum R3B2 was not known to occur in the region in which the 
articles were produced.
    We received comments on that interim rule requesting that we 
establish a certification program for articles of Pelargonium spp. and 
Solanum spp. imported from countries where R. solanacearum R3B2 is 
known to occur.
    In addition, an introduction of the bacterium into the United 
States via infected geranium cuttings (Pelargonium spp.) was confirmed 
in February 2003; during the subsequent eradication effort, APHIS found 
some infected articles of Pelargonium spp.

[[Page 61352]]

that we believed were imported after the effective date of the May 2003 
interim rule. This indicated to us that additional mitigations against 
the risk of introducing R. solanacearum R3B2 via imported articles of 
Pelargonium spp. and Solanum spp. were necessary.
    Accordingly, in a subsequent interim rule effective May 24, 2004, 
and published in the Federal Register on April 23, 2004 (69 FR 21941-
21947, Docket No. 03-019-2), we amended the regulations by requiring 
that articles of Pelargonium spp. and Solanum spp. imported from 
countries where R. solanacearum R3B2 is known to occur be grown in 
accordance with a certification program. The certification program, 
which includes production site construction requirements, testing 
requirements, and operational requirements, is designed to ensure that 
R. solanacearum R3B2 will not be introduced into the United States via 
the importation of articles of Pelargonium spp. and Solanum spp. The 
interim rule also required that imported articles of Pelargonium spp. 
and Solanum spp. from countries where the bacterium R. solanacearum 
R3B2 is known to occur be accompanied by a phytosanitary certificate 
with an additional declaration stating that the articles were produced 
in accordance with the requirements of the certification program. We 
took this action based on our determination that the restrictions that 
had been added to the regulations in the May 2003 interim rule did not 
adequately mitigate the risk that imported articles of Pelargonium spp. 
and Solanum spp. could introduce this bacterial strain into the United 
States.
    We solicited comments concerning the April 2004 interim rule for 60 
days ending June 22, 2004. We received 10 comments by that date. They 
were from State and foreign plant protection organizations, nursery 
stock growers, industry associations, and university researchers. We 
have carefully considered all of the comments we received. They are 
discussed below by topic.

General Comments

    Two commenters asserted that the available scientific evidence did 
not support placing any restrictions on the importation of articles of 
Pelargonium spp. and Solanum spp. to prevent the introduction of R. 
solanacearum R3B2, further claiming that the decision to establish the 
certification program in the April 2004 interim rule was driven by 
politics rather than science. One of these commenters also stated that 
there is no evidence that articles of Pelargonium spp. that are 
infected with R. solanacearum R3B2 pose a threat to the environment in 
general or potatoes in particular, noting that the recent introductions 
of the bacterium that had prompted our interim rules had not resulted 
in any introductions of R. solanacearum R3B2 into the environment. 
(Potatoes were identified in the analysis under the heading ``Executive 
Order 12866 and Regulatory Flexibility Act'' in both interim rules as 
the Solanum crop that could experience the greatest magnitude of 
negative economic effects if R. solanacearum R3B2 was introduced into 
the United States.)
    The Animal and Plant Health Inspection Service (APHIS) considers R. 
solanacearum R3B2 to be a quarantine pest. The bacterium is not known 
to occur in the United States; 10 years of field surveys undertaken by 
APHIS and by State governments have failed to discover any evidence of 
R. solanacearum R3B2 in the environment.
    As mentioned above, an introduction of the bacterium into the 
United States via infected geranium cuttings (Pelargonium spp.) was 
confirmed in February 2003. The bacterium was subsequently eradicated; 
more than 2.1 million plants at 471 greenhouses throughout the United 
States were destroyed as part of the eradication effort. The 
eradication effort was, as one of the commenters noted, successful at 
preventing the introduction of R. solanacearum R3B2 into the wider U.S. 
environment. The survey procedures used to make this determination are 
described in detail in the 2004 New Pest Response Guidelines (Action 
Plan) issued in response to the introduction of R. solanacearum R3B2 
into the United States.\1\
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    \1\ This document may be viewed on the Internet at http://www.aphis.usda.gov/ppq/ep/ralstonia/rasltoniaactionplanv4web.pdf. 
Copies of all documents related to APHIS' response to the 
introduction of R. solanacearum R3B2 into the United States may also 
be requested from the person listed under FOR FURTHER INFORMATION 
CONTACT.
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    Experiences in other countries suggest that if R. solanacearum R3B2 
were to become established in the United States, it would have a 
significant impact on U.S. potato production; the bacterium causes 
potatoes to rot through, making them unusable and seriously affecting 
potato yields. In addition, if R. solanacearum R3B2 were to be 
introduced into the U.S. environment, the bacterium would be extremely 
difficult to eradicate, both because of its many alternate hosts and 
because of its ability to survive in water. Letting an infected field 
lie fallow or using alternate, non-potato crops for a growing season is 
not effective as a means of eradicating R. solanacearum R3B2, as the 
bacterium survives in various common weeds, including Solanum species 
such as nightshade. The bacterium can also be transmitted from infected 
fields to other fields by streams and runoff. Therefore, it is 
imperative that APHIS implement measures restrictive enough to prevent 
R. solanacearum R3B2 from being introduced into the United States via 
the importation of potentially infected articles. The requirements of 
the certification program are designed to meet that goal.
    Typically, APHIS simply prohibits the importation of articles of 
nursery stock that pose a risk of introducing plant pathogens such as 
R. solanacearum R3B2 into the United States, as plant pathogens are 
substantially more difficult to detect and neutralize than other plant 
pests. However, as indicated in the analysis under the heading 
``Executive Order 12866 and Regulatory Flexibility Act'' in the April 
2004 interim rule, the United States imports substantial quantities of 
Pelargonium spp., and we did not want to halt this trade if there was 
an effective alternative. We believe the requirements of the 
certification program strike a balance by allowing continued 
importation of articles of Pelargonium spp. and Solanum spp. but 
ensuring that such importation does not introduce R. solanacearum R3B2 
into the United States.
    One commenter asserted that the requirements of the certification 
program are identical to the requirements of the Minimum Sanitation 
Protocols for Offshore Geranium Cutting Production that APHIS issued in 
response to the February 2003 introduction of R. solanacearum R3B2 via 
imported geranium cuttings.\2\ The commenter asked what assurance we 
have that the certification program will be effective, since some 
infected geranium cuttings appeared to have entered the United States 
after the Minimum Sanitation Protocols were issued.
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    \2\ The Minimum Sanitation Protocols for Offshore Geranium 
Cutting Production may be viewed on the Internet at http://www.aphis.usda.gov/ppq/ep/ralstonia/ralstoniaworkplan.pdf.
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    We believe that the apparent entry of infected geranium cuttings 
after the Minimum Sanitation Protocols were issued was due to the 
failure of one importer to properly implement the Minimum Sanitation 
Protocols, rather than a deficiency in the protocols themselves. (The 
Minimum Sanitation

[[Page 61353]]

Protocols contain requirements that are similar to, but more specific 
than, the requirements of the certification program.) We continue to 
believe that the requirements of the certification program will be 
effective at preventing the introduction of R. solanacearum R3B2 into 
the United States if they are properly implemented under the oversight 
of APHIS and the national plant protection organization (NPPO) of the 
country of origin of the imported articles. Adding the certification 
program to the regulations via our April 2004 interim rule helped to 
ensure that any production requirements imposed by APHIS are properly 
implemented. We are making no changes to the April 2004 interim rule in 
response to this comment.
    One commenter stated that the workplans developed among APHIS, the 
NPPOs of exporting countries, and the owners or operators of production 
sites need to address operational details of production under the 
certification program more specifically than the regulations 
established by the April 2004 interim rule do.
    We agree with this comment. The regulations describing the 
certification program are intended to establish the necessary 
performance standards, while the workplans cited by the commenter are 
intended to describe in greater detail what needs to be done at a 
specific production site or sites to meet these standards. We have 
prepared a workplan for this program by combining the Minimum 
Sanitation Protocols for Offshore Geranium Cutting Production with a 
testing and sampling plan and a signature page, which is signed by 
APHIS and the NPPO of each exporting country. The workplan requires the 
inspection personnel of the exporting country's NPPO to work in 
conjunction with APHIS when appropriate, and to provide the oversight 
needed to demonstrate that each production site will carry out the 
procedures, sampling, and testing described in the workplan. 
Additionally, the workplan requires the exporting country's NPPO to 
provide the proper phytosanitary certification of all host material, 
which includes the additional declaration ``Tested and found free of 
Ralstonia solanacearum race 3 biovar 2.''
    One commenter suggested that APHIS establish a Web site that would 
provide updates to the public whenever the best management practices 
associated with growing articles of Pelargonium spp. and Solanum spp. 
are changed.
    APHIS maintains documents pertaining to R. solanacearum R3B2 on the 
Plant Protection and Quarantine Web page, at http://www.aphis.usda.gov/ppq/ep/ralstonia/index.html. That Web site hosts the documents cited 
in this final rule related to the production of articles of Pelargonium 
spp. and Solanum spp. for export to the United States in countries or 
areas where R. solanacearum R3B2 is known to occur, along with more 
general information about APHIS efforts to prevent the introduction of 
the bacterium into the United States. We will continue to update that 
Web page to reflect advances in scientific knowledge and amendments to 
our regulations regarding R. solanacearum R3B2, including changes to 
the best management practices associated with growing articles of 
Pelargonium spp. and Solanum spp.

Characteristics of R. solanacearum R3B2

    The April 2004 interim rule included information about the means by 
which R. solanacearum R3B2 can spread and the reasons it is difficult 
to eradicate. This information is presented above under the heading 
``General Comments'' in the context of discussing why it was necessary 
to restrict the importation of articles of articles of Pelargonium spp. 
and Solanum spp.; it served a similar function in the interim rule. We 
received several comments concerning this information.
    One commenter stated that the spread of R. solanacearum R3B2 from 
field to field via run-off water had never been substantiated to the 
commenter's knowledge in Europe. This commenter cited establishment in 
wild bittersweet (Solanum duclamara) and subsequent irrigation with 
contaminated surface water as of more importance. Another commenter 
stated that no scientific evidence suggests that R. solanacearum R3B2 
can survive in water.
    Once R. solanacearum R3B2 is introduced into the environment, its 
primary means of spread is via contaminated run-off water or irrigation 
water. This has been proven by experiences in the United Kingdom 
(UK).\3\ Furthermore, the first commenter provided additional evidence 
that suggests it is necessary to address the risk of transmission of 
the bacterium into a production site via contaminated water.
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    \3\ Summarized by John Elphinstone, Central Science Laboratory, 
Department for Environment, Food, and Rural Affairs, York, UK, in 
``Monitoring and control of the potato brown rot bacterium 
(Ralstonia solanacearum) in the UK.'' This presentation was given at 
``Planning for Ralstonia solanacearum R3B2 Detection on Solanaceous 
Crops in the U.S.,'' meeting held at APHIS headquarters on June 19, 
2003.
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    In response to the second commenter's assertion, the bacterium does 
not survive indefinitely in water, as it requires food to metabolize, 
but it can survive for the limited time required for plant-to-plant 
transmission via run-off water.
    One commenter stated that Pelargonium spp. are not preferred hosts 
for R. solanacearum R3B2, so crop losses in Pelargonium spp. due to the 
bacterium are minimal and can be easily eliminated by proper production 
practices. This commenter also stated that R. solanacearum R3B2 rarely 
results in substantial yield losses in potatoes in cooler climates, and 
a proper control program can cause it to occur only sporadically and 
easily eliminate it from the production column.
    We agree with the commenter's statement regarding the host status 
of Pelargonium spp. for R. solanacearum R3B2; however, since infected 
articles of Pelargonium spp. have introduced R. solanacearum R3B2 into 
the United States, necessitating eradication efforts that were costly 
both to APHIS and to U.S. nursery stock growers, we believe it is 
necessary to regulate their importation from countries where R. 
solanacearum R3B2 is known to occur.
    With regard to the commenter's assertions about the potential 
impact of R. solanacearum R3B2 on potato crops, it should be reiterated 
that R. solanacearum R3B2 is a quarantine pest that is not known to 
occur in the United States. It can be difficult to predict the impact 
of a plant pest in a new environment. In addition, if R. solanacearum 
R3B2 were introduced into the United States, APHIS would likely place a 
quarantine on any areas of the United States where the bacterium was 
known to occur, which would result in increased production costs for 
U.S. producers of articles of Pelargonium spp. and Solanum spp. and the 
possible loss of export markets for such articles. As described in the 
analysis under the heading ``Executive Order 12866 and Regulatory 
Flexibility Act'' in both interim rules, losses for U.S. potato 
producers due to quarantines and reduced export markets could 
potentially amount to hundreds of millions of dollars in the event of 
an introduction of R. solanacearum R3B2 into the United States. We do 
not believe that the information cited by the commenter warrants 
reconsideration of R. solanacearum R3B2's status as a quarantine pest 
or warrants relaxing any of the restrictions on the importation of 
articles of Pelargonium spp. and Solanum spp. that we added to the 
regulations in the two interim rules.
    One commenter felt that our use of the term ``dangerous'' to 
describe R. solanacearum R3B2 and our statement

[[Page 61354]]

that an introduction of R. solanacearum R3B2 into the United States 
``could be devastating to U.S. potato production'' were unnecessarily 
inflammatory.
    Our use of the term ``dangerous'' was intended to indicate that R. 
solanacearum R3B2 has the potential to cause economic damage to crops 
in the United States if it is introduced and spreads to the wider 
environment. Similarly, our use of the term ``devastating'' to describe 
the potential impact of R. solanacearum R3B2 on U.S. potato production 
was intended to reflect the fact that if potato brown rot were to 
become established in the United States, the potato industry could 
potentially lose hundreds of millions of dollars due to direct losses 
and indirect losses from quarantines and diminished export markets. 
(These possibilities were discussed in the analysis under the heading 
``Executive Order 12866 and Regulatory Flexibility Act'' in both 
interim rules.) To address this commenter's concern, in the preamble to 
this final rule, we will refer more directly to the potential economic 
impact of R. solanacearum R3B2 when discussing the importance of 
preventing its introduction into the United States. No changes to the 
regulations established by the two interim rules are necessary as a 
result of this comment.
    We also received comments regarding two other characteristics of R. 
solanacearum R3B2.
    First, both interim rules restricted the importation of articles of 
Pelargonium spp. and Solanum spp.; the term ``articles'' is understood 
to refer to both plants and all propagative material that can be 
derived from a plant, including seed. Two commenters disputed the 
implied assertion that R. solanacearum R3B2 could be transmitted via 
seed and asked us to exempt seed of Pelargonium spp. and Solanum spp. 
imported from countries where the bacterium exists from the 
requirements established by the two interim rules.
    The commenters are correct that R. solanacearum R3B2 is not a 
seedborne pathogen and that we should, therefore, exempt seeds from the 
requirements for imported articles of Pelargonium spp. and Solanum spp. 
that we established in Sec.  319.37-5(r) in the two interim rules. We 
have done so in this final rule by adding a statement to the 
introductory text of Sec.  319.37-5(r) stating that seeds are not 
subject to that paragraph's requirements. (We are not amending the 
entries for ``Pelargonium spp. not meeting the conditions for 
importation in Sec.  319.37-5(r)'' and ``Solanum spp. not meeting the 
conditions for importation in Sec.  319.37-5(r)'' in the table of 
prohibited articles in Sec.  319.37-2(a), because the entries for 
prohibited articles in that table include seed only if specifically 
mentioned.)
    Although we are exempting seed from the requirements of paragraph 
Sec.  319.37-5(r) in this final rule, we will refer simply to 
``articles of Pelargonium spp. and Solanum spp.'' in the following 
discussion of comments for ease of reading.
    Second, both interim rules also limited the articles that were 
regulated to those of Pelargonium spp. and Solanum spp. One commenter 
asked if the host range of R. solanacearum R3B2 was limited to articles 
of Pelargonium spp. and Solanum spp., and stated that if it is not, the 
importation of asexual propagative material from the entire host range 
of the bacterium should be restricted.
    We agree that other plants can serve as hosts for R. solanacearum 
R3B2, and we are reviewing the available evidence regarding plants that 
may serve as hosts for R. solanacearum R3B2. If necessary, we will 
conduct further rulemaking to address any risks their importation may 
pose. Such an action would afford the public, and foreign producers of 
these species in particular, an opportunity to comment on the 
suitability and effectiveness of the certification program's 
requirements for production of those species. Thus, we are making no 
changes to the regulations established by the two interim rules in 
response to this comment.

R. solanacearum in the United States

    In the April 2004 interim rule, we made the following statements 
about the presence of R. solanacearum in the United States:
    ``At least three biovars of R. solanacearum race 3 are 
distinguished on the basis of biochemical properties. Biovar 1, which 
is currently established in the United States, does not tolerate cold 
temperatures; its establishment is thus limited to the southern part of 
the United States. However, biovar 2, which is not present in the 
United States, is adapted to low temperatures and is found in temperate 
zones, meaning that it could thrive in the northern States where most 
U.S. potatoes are produced. If R. solanacearum race 3 biovar 2 were to 
become established in the United States, it would likely have a 
devastating impact on potato production.
    ``Biovar 1 is currently established in the United States, and we 
have not established an official control program for it. Therefore, in 
accordance with international trade agreements, we cannot place 
restrictions on the importation of articles that may be infected with 
biovar 1. Biovar 2, however, is not established in the United States 
and is considered a pest of quarantine significance. Therefore, under 
those same international agreements, we are free to place restrictions 
on the importation of articles that may be infected with biovar 2.''
    We received several comments regarding these statements.
    One commenter stated that it is not R. solanacearum race 3 biovar 1 
that does not tolerate cold temperatures and that is present in the 
United States, but rather R. solanacearum race 1 biovar 1.
    At the time the commenter submitted this comment, during the 60 
days after the publication of the April 2004 interim rule, the 
commenter was correct. The races of R. solanacearum are distinguished 
on the basis of their primary hosts; race 1 causes bacterial wilt on 
tomatoes, while race 3 causes brown rot on potatoes. Both race 1 and 
race 3 can infect hosts other than their primary hosts. R. solanacearum 
race 1 biovar 1 is established in the southeast United States.
    A strain of Ralstonia was discovered in samples from a greenhouse 
and pond in the State of Florida in September 2004. It was eventually 
identified as R. solanacearum biovar 1, but testing has to this point 
produced conflicting results as to what race of the bacterium is 
present in the samples. Regardless, APHIS is not treating any R. 
solanacearum of biovar 1 as a quarantine pest.
    In the absence of further information regarding the strain of R. 
solanacearum that we discovered in Florida in September 2004, we will 
refer to the strain of R. solanacearum that is present in the United 
States as race 1 biovar 1 in the preamble of this final rule. However, 
because the interim rules addressed R. solanacearum R3B2 and the 
bacterium present in Florida has been determined not to be a biovar 2 
R. solanacearum bacterium, no changes to the regulations established by 
the two interim rules are necessary as a result of this comment.
    Two commenters asked APHIS to present evidence that R. solanacearum 
R3B2 is not present in the United States. These commenters stated that 
U.S. potato growers are not required to test wilted plants for R. 
solanacearum R3B2, which means that it is unknown whether R. 
solanacearum R3B2 exists in U.S. potatoes. Another commenter took issue 
with our statement that R. solanacearum R3B2 is not present in the 
United States, since APHIS conducted a recent eradication effort 
against the bacterium, and suggested that we state

[[Page 61355]]

instead that we are attempting to eradicate R. solanacearum R3B2 within 
the United States.
    All of the available data indicate that our eradication effort has 
been successful at preventing R. solanacearum R3B2 from becoming 
established within the United States. Data from surveys conducted both 
by APHIS and by State governments indicate that R. solanacearum R3B2 is 
not present in the United States.
    Potato growers within the United States are not required by APHIS 
to test their wilted plants for R. solanacearum R3B2 because the 
bacterium is not known to occur in the United States. If R. 
solanacearum R3B2 were known to occur in the United States, we would 
establish a domestic quarantine in order to pursue its eradication or 
containment. Such a quarantine would be likely to include a requirement 
that potato growers submit wilted plants for testing.
    Many States have potato certification programs to ensure freedom 
from disease and to improve marketability for their potato crops. These 
State programs require potato producers to test for disease organisms 
that may occur in the production cycle if the potato plants show 
symptoms such as wilting. These programs do not specifically seek to 
identify R. solanacearum R3B2 infections because the bacterium is not 
known to occur in the United States, but the presence of symptoms 
caused by R. solanacearum R3B2 infection would indicate that a disease 
is present, and the potatoes would be subsequently tested for diseases, 
including R. solanacearum R3B2, until the cause of the symptoms was 
determined.
    As indicated above, survey data indicate that R. solanacearum R3B2 
is not present in the United States; these data are what led us to the 
conclusion that R. solanacearum R3B2 is not known to occur in the 
United States.
    One commenter cited three publications that the commenter believed 
could indicate that R. solanacearum R3B2 is present in the United 
States:
    <bullet> In a 1979 finding of R. solanacearum drawn from 
Pelargonium x hortorum in the United States,\4\ the race and biovar of 
the bacterium were unclear, but pathogenicity tests showed that the 
isolates from the plant failed to cause disease on tobacco, which the 
commenter asserted was typical of R. solanacearum R3B2. However, this 
finding would also be consistent with R. solanacearum race 1 biovar 1, 
which APHIS has acknowledged is established in the United States. 
Therefore, no definitive statement about the presence of R. 
solanacearum R3B2 in the United States can be made based on this 
finding.
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    \4\ Strider, D.L., Jones, R.K., and Haygood, R.A. 1981. 
``Southern bacterial wilt of geranium caused by Pseudomonas 
solanacearum,'' Plant Disease 65: 52-53.
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    <bullet> The commenter pointed out that R. solanacearum R3B2 was 
found on Pelargonium zonale in Wisconsin in 1999.\5\ However, the 
bacterium was found only in greenhouses; APHIS eradicated the bacterium 
after it was found, and there is no evidence that it was transmitted 
into the wider U.S. environment.
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    \5\ Hudelson, B.D. 1999. ``Southern wilt.'' University of 
Wisconsin Garden Facts, May 11, 1999.
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    <bullet> The commenter also noted that R. solanacearum race 1 
biovar 1 has been found on P. zonale in Ohio.\6\ R. solanacearum race 1 
biovar 1, as noted above, is established in the United States, and 
APHIS has not established an official control program for it. The 
interim rules placed restrictions on the importation of articles of 
Pelargonium spp. and Solanum spp. to prevent the introduction of R. 
solanacearum R3B2.
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    \6\ Nameth, S. 1999. ``Bacterial disease alert in geraniums.'' 
FlowerTECH2 4: 65-67.
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    This commenter also asked for information on official control of R. 
solanacearum in the United States. As described above, R. solanacearum 
race 1 biovar 1 is established in the United States, and APHIS has not 
established an official control program for it, nor have we established 
an official control program for any other biovar of race 1. We do not 
have an official control program for R. solanacearum R3B2 because that 
strain of the bacterium is not known to occur in the United States. 
Races 2, 4, and 5 are also not known to occur in the United States. As 
mentioned earlier in this document, we are not treating the R. 
solanacearum biovar 1 bacterium found in Florida as a quarantine pest.
    Two commenters stated that they were not aware of any evidence that 
R. solanacearum R3B2 could survive in a northern climate. Another 
commenter argued that our assertion that R. solanacearum R3B2 is 
adapted to low temperatures may not be justified by the available 
evidence and suggested that we state instead that R3B2 ``appears to be 
adapted to lower temperatures.''
    Janse (1996) indicates that R3B2 is, in fact, adapted to low 
temperatures.\7\ If we become aware of any new research disputing the 
existing evidence, we will evaluate it and, if necessary, update the 
regulations.
---------------------------------------------------------------------------

    \7\ Janse, J. D. 1996. ``Potato brown rot in Western Europe--
History, presence, occurrence and some remarks on possible origin, 
epidemiology and control strategies.'' EPPO Bull. 26: 679-985.
---------------------------------------------------------------------------

Distribution of R. solanacearum in Other Countries

    In the May 2003 interim rule, we listed the following countries as 
countries where R. solanacearum R3B2 is not known to occur: Algeria, 
Austria, Belarus, Bulgaria, Canada, Croatia, Cyprus, Czech Republic, 
Denmark, Estonia, Finland, Greece, Ireland, Israel, Italy, Latvia, 
Lithuania, Moldavia, Morocco, Norway, Poland, Portugal, Romania, 
Russian Federation, Slovakia, Slovenia, Spain, Sweden, Switzerland, 
Tunisia, and Ukraine. (We did not provide this list in the April 2004 
interim rule; one commenter on that interim rule asked that we provide 
it here.) Two comments on the April 2004 interim rule raised issues 
related to this list.
    The April 2004 interim rule exempted articles of Solanum spp. from 
Canada from the requirement that the phytosanitary certificate 
accompanying articles of Solanum spp. must contain an additional 
declaration; Canada is the only country allowed to export articles of 
Solanum spp. other than true seed to the United States, as the 
importation of Solanum spp. other than seed from other countries is 
prohibited due to other disease risks. One commenter asked whether R. 
solanacearum R3B2 might have entered Canada after it entered the United 
States in 2003.
    We are aware of no evidence suggesting that R. solanacearum R3B2 
has occurred in Canada, and the Canadian NPPO has not reported its 
presence. All the evidence available indicates that APHIS was 
successful at confining the R. solanacearum R3B2 in the United States 
to a few hundred facilities and that the bacterium was not transmitted 
into the wider environment in the United States, much less in Canada. 
As a signatory nation to the International Plant Protection Convention 
(IPPC) of the United Nations' Food and Agriculture Organization, Canada 
is obligated to report any discoveries of R. solanacearum R3B2 to the 
IPPC.
    One commenter, the Secretaria de Agricultura, Ganader[iacute]a, 
Desarrollo Rural, Pesca y Alimentaci[oacute]n of Mexico (SAGARPA, 
Mexico's NPPO), requested that Mexico be added to the list of countries 
where R. solanacearum R3B2 is not known to occur. The commenter stated 
that the only article that states that R. solanacearum R3B2 occurs in 
Mexico, a 1978 publication by Dr. Leopoldo Fucikovsky, used an oxidase 
test to determine that R. solanacearum

[[Page 61356]]

R3B2 was present. The oxidase test is inadequate to establish the 
presence of R. solanacearum R3B2 since the test reacts not only with R. 
solanacearum R3B2 but also with phenols and other plant chemistry 
components. According to the commenter, all recent studies regarding 
the occurrence of R. solanacearum R3B2 have not discovered the 
bacterium in Mexico. The commenter also stated that Mexico performs 
surveys for R. solanacearum R3B2 using enzyme-linked immunosorbent 
assays (ELISA) and polymerase chain reaction (PCR) tests and has found 
no evidence of the bacterium.
    SAGARPA did not provide citations for the studies it cited as 
supporting its view. If SAGARPA wishes to provide us with more specific 
information establishing Mexico's freedom from R. solanacearum R3B2, 
such as parameters of any surveys undertaken and the results of those 
surveys, we will consider it. Alternatively, SAGARPA may propose to 
establish an area within Mexico as free of R. solanacearum R3B2; the 
process for doing so is described in more detail under the heading 
``Pest-Free Areas and Nurseries,'' which follows directly.

Pest-Free Areas and Nurseries

    The April 2004 interim rule requires that articles of Pelargonium 
spp. and Solanum spp. that are imported into the United States from a 
country where R. solanacearum R3B2 is known to occur be produced in 
accordance with the certification program established by that interim 
rule. Two commenters acknowledged the necessity of placing restrictions 
on the importation of articles other than seed of Pelargonium spp. and 
Solanum spp. from countries where R. solanacearum R3B2 is known to 
occur, but stated that the requirements of the certification program 
are unnecessarily restrictive given the phytosanitary controls already 
in place in certain countries that export articles of Pelargonium spp. 
and Solanum spp. These two commenters asked that we recognize areas 
within a country where R. solanacearum R3B2 is known to occur as areas 
free of R. solanacearum R3B2.
    APHIS recognizes areas within a country as being free of plant 
pests in accordance with the requirements in International Standards 
for Phytosanitary Measures (ISPM) Publication No. 4, ``Requirements for 
the Establishment of Pest Free Areas,'' which was published in 1996 by 
the IPPC and which is incorporated by reference into our regulations at 
7 CFR 300.5.\8\ To establish a pest-free area under this standard, a 
country must establish three main components: Systems to establish 
freedom, phytosanitary measures to maintain freedom, and checks to 
ensure that freedom has been maintained. The standard sets out 
performance-based requirements relating to each of these three 
components. Any country wishing to establish an area within its borders 
as free of R. solanacearum R3B2 may submit the appropriate information 
in accordance with ``Requirements for the Establishment of Pest Free 
Areas'' and propose that APHIS recognize the area in question as an 
area that is free of R. solanacearum R3B2. APHIS will evaluate whether 
the components the country has established are sufficient to establish 
the area as a pest-free area. At the present time, no foreign NPPO has 
submitted such a proposal.
---------------------------------------------------------------------------

    \8\ ISPM publications can be viewed on the Internet at https://www.ippc.int/id/13399.
---------------------------------------------------------------------------

    However, the regulations established by the two interim rules do 
not explicitly provide for the possible recognition of an area within a 
country as free of R. solanacearum R3B2. To allow for this possibility, 
we are adding a new paragraph (r)(2)(ii) to the regulations in Sec.  
319.37-5. This paragraph will exempt articles of Pelargonium spp. and 
Solanum spp. imported from areas free of R. solanacearum R3B2 within 
countries where R. solanacearum R3B2 is known to occur from the 
requirements of the certification program. Instead, such articles will 
be required to be accompanied by a phytosanitary certificate containing 
an additional declaration that states ``This article is from an area 
that has been established as free of Ralstonia solanacearum race 3 
biovar 2.'' We are moving the requirements presently in paragraph 
(r)(2) into a new paragraph (r)(2)(i) to accommodate this change.
    These two commenters also asked that we recognize the growing 
practices in certain nurseries as sufficient to ensure the freedom of 
articles of Pelargonium spp. and Solanum spp. produced in those 
nurseries from R. solanacearum R3B2.
    One of these commenters noted that the presence of R. solanacearum 
R3B2 in the UK has been minimized. All production of potato and tomato 
within the European Union (EU) is under official compliance with EU 
production directive 98/57/EC. The requirements of this directive have 
ensured that outbreaks of potato brown rot and tomato bacterial wilt (a 
disease caused in tomatoes by R. solanacearum R3B2) have been contained 
at the place of production. Directive 98/57/EC also includes measures 
for the safe disposal of any infected crops, therefore removing any 
possibility of the pathogen's spread through trade. Furthermore, annual 
surveys conducted by the UK's NPPO ensure that the current locations of 
contaminated watercourses are known and that irrigation from such 
sources is prohibited. As a result, only five cases of the disease have 
been detected in ware potato crops, and only one case has been detected 
in tomatoes. The commenter stated that there have been no findings of 
R. solanacearum R3B2 in the UK since 2000.
    The other commenter asked specifically that we exclude Solanum 
nigrum produced under protected cultivation from the final rule. The 
commenter also stated that R. solanacearum R3B2 is not known to occur 
in some nurseries producing Pelargonium spp. in EU Member States. The 
commenter further argued that, if growing practices are sufficient to 
exclude R. solanacearum R3B2 from a production site, the testing 
provisions of the certification program would be superfluous.
    We believe that the requirements of the certification program are 
all essential to ensuring that articles of Pelargonium spp. and Solanum 
spp. that are imported into the United States from a country where R. 
solanacearum R3B2 is known to occur do not introduce that bacterium 
into the United States. Accordingly, we will recognize the growing 
practices in certain nurseries (including protected cultivation) as 
sufficient to ensure the freedom of articles produced in those 
nurseries from R. solanacearum R3B2 only if those practices satisfy the 
requirements of the certification program. Growers in countries where 
R. solanacearum R3B2 is known to occur who believe that their 
production practices satisfy the requirements of the certification 
program may request to have those production practices evaluated by 
APHIS.
    With regard to the first commenter's description of production 
practices in the UK, we consider the UK to be a country where R. 
solanacearum R3B2 is known to occur, and the commenter did not dispute 
that. If certain areas in the UK are believed to be free of R. 
solanacearum R3B2, the NPPO of the UK may attempt to establish their 
pest-free status by submitting the information required by ISPM 
Publication No. 4 to APHIS for further evaluation as described above. 
Otherwise, UK growers should request

[[Page 61357]]

to have their production practices recognized by APHIS as satisfying 
the requirements of the certification program.
    We disagree with the second commenter's assertion that testing is 
superfluous in a production site that has taken measures to exclude R. 
solanacearum R3B2. Just as the establishment of a pest-free area 
requires checks to ensure that the area remains free of the relevant 
pest, testing is an important means of ensuring that the measures a 
production site has taken to exclude R. solanacearum R3B2 are being 
properly implemented and thus excluding the bacterium. We are making no 
changes to the April 2004 interim rule in response to these comments.

Testing for R. solanacearum R3B2

    One commenter asked us to specify what criteria must be met to 
determine whether an area is free of R. solanacearum R3B2 and what 
tests may be used to determine that a production site is free of R. 
solanacearum R3B2.
    As mentioned earlier in this document, the determination that an 
area is free of a pest is based on our assessment of components that 
include, but are not limited to, regular checks to ensure that the area 
remains free of the pest. Testing may be carried out using any means 
that the country in which the proposed pest-free area is located deems 
practical and that APHIS determines to be effective.
    The April 2004 interim rule stated that we are currently aware of 
two acceptable methods for testing production sites: An ELISA, which 
can determine whether Ralstonia spp. bacteria are present, and a PCR 
test that can determine whether R. solanacearum R3B2 bacteria are 
present. Domestic greenhouses tested for R. solanacearum R3B2 during 
the recent eradication effort typically used ELISA to screen 
potentially symptomatic material; if the material was infected with 
Ralstonia spp., the PCR test was used to determine whether those 
bacteria were race 3, biovar 2. Other testing methods may be used if 
APHIS determines that those methods are adequate to confirm that 
production facilities are free of R. solanacearum R3B2.
    The preamble of the April 2004 interim rule stated: ``One approach 
to preventing the entry of R. solanacearum R3B2 would be to test 
articles of Pelargonium spp. and Solanum spp. that are offered for 
importation into the United States at the port of entry. For such an 
approach to be effective, our tests would need to be able to 
distinguish between the biovars of the bacterium and to identify the 
presence of R. solanacearum R3B2. However, there currently exists no 
standalone, specific test for R. solanacearum race 3 biovar 2 that is 
practical for testing articles of Pelargonium spp. and Solanum spp. at 
ports of entry.'' One commenter stated that testing for R. solanacearum 
R3B2 at ports of entry is quite possible; alternatively, imported 
articles could be tested during postentry inspections of the nurseries 
where the articles are further cultivated.
    We do not dispute that such testing is possible; however, APHIS 
currently lacks the infrastructure and resources to either perform the 
PCR test at the port of entry or perform an ELISA at the port of entry, 
hold the tested articles until the test results are available, and then 
run a separate PCR test on any articles that tested positive by ELISA 
for the presence of Ralstonia spp. Therefore, we have focused our 
efforts on excluding R. solanacearum R3B2 from articles offered for 
importation into the United States.

Specific Provisions of the Certification Program

    The April 2004 interim rule added a definition of production site 
to Sec.  319.37-1 that read: ``A defined portion of a place of 
production utilized for the production of a commodity that is managed 
separately for phytosanitary purposes. This may include the entire 
place of production or portions of it. Examples of portions of places 
of production are a defined orchard, grove, field, greenhouse, 
screenhouse, or premises.'' This definition was taken from ISPM 
Publication No. 5, ``Glossary of Phytosanitary Terms 2002.'' \9\
---------------------------------------------------------------------------

    \9\ ISPM publications can be viewed on the Internet at https://www.ippc.int/id/13399.
---------------------------------------------------------------------------

    One commenter stated that this definition might cause confusion 
with regard to some of the requirements of the certification program. 
For example, Sec.  319.37-5(r)(3)(iv) of the certification program 
established by the April 2004 interim rule requires the production site 
for articles of Pelargonium spp. and Solanum spp. to be surrounded by a 
1-meter buffer. The commenter suggested that, given the definition of 
production site established in the April 2004 interim rule, this 
requirement could be interpreted to mean that an entire farm, composed 
of multiple greenhouses in which articles of Pelargonium spp. and 
Solanum spp. are produced, is required to be surrounded by a buffer, 
rather than the individual greenhouses. The commenter cited similar 
potential problems regarding the certification program's requirement in 
Sec.  319.37-5(r)(3)(v) that the buffer be kept free of dicotyledonous 
weeds.
    The definition of production site established in the April 2004 
interim rule states that the production site may include ``the entire 
production site or portions of it. Examples of portions of places of 
production are a defined orchard, grove, field, greenhouse, 
screenhouse, or premises.'' Under this definition, on a farm that is 
managed as a single production site for phytosanitary purposes but is 
composed of multiple greenhouses, each individual greenhouse in the 
farm is considered to be a portion of the production site. (Individual 
greenhouses are considered to be individual production sites only if 
they are managed separately for phytosanitary purposes, as provided for 
in the definition.) Thus, the production site in this case would not 
include all the land of the farm on which the greenhouses are located 
but rather all the portions of the farm in which production of articles 
of Pelargonium spp. and Solanum spp. takes place--the individual 
greenhouses. Thus, each individual greenhouse on such a farm would be 
required to have a 1-meter buffer that is kept free of dicotyledonous 
weeds.
    We are making no changes to the definition of production site in 
response to this comment. However, we are revising paragraphs 
(r)(3)(iv) and (r)(3)(v), which refer to the production site in the 
context of the requirements the commenter mentioned, to clarify that 
these requirements apply to each greenhouse on the production site 
rather than the entire production site. We believe these changes 
addresses the commenter's concern.
    Paragraph (r)(3)(iii) of the certification program established in 
Sec.  319.37-5 by the April 2004 interim rule required that production 
sites conduct ongoing testing for R. solanacearum R3B2 and that only 
those articles of Pelargonium spp. and Solanum spp. that have been 
tested with negative results for the presence of R. solanacearum R3B2 
may be used in production and export. One commenter was concerned that 
this requirement could be interpreted to mean that each article 
exported to the United States must be tested.
    We did not intend to require that each article used in production 
and export be tested individually; rather, we intended to require that 
each article that has been used in production and export be part of a 
group of articles that has been tested in accordance with a protocol 
sufficient to determine, with a high degree of certainty, whether the 
articles in the group are infected with R. solanacearum R3B2. Details 
of the

[[Page 61358]]

testing and the statistical plan for the testing protocol are specified 
in the workplan developed by APHIS, the foreign NPPO, and the owner or 
operator of the production site.
    The commenter is correct in stating that the language in the April 
2004 interim rule is ambiguous on this point. Therefore, we are 
amending paragraph (r)(3)(iii) to state that only articles of 
Pelargonium spp. and Solanum spp. from a group of articles that has 
been tested according to an APHIS-approved testing protocol with 
negative results for the presence of R. solanacearum R3B2 may be used 
in production and export.
    Paragraph (r)(3)(iv) of the certification program established by 
the April 2004 interim rule required that the production site be 
constructed in a manner that ensures that outside water cannot enter 
the production site. One commenter pointed out that water is necessary 
to grow plants, and this water must be brought into the production site 
from outside the production site; the interim rule technically excluded 
such water. The commenter suggested changing the requirement to state 
that the production site must be constructed in a manner that ensures 
that runoff water from areas surrounding the production site cannot 
enter the production site.
    We agree with this comment and have changed paragraph (r)(3)(iv) of 
the certification program established by the April 2004 interim rule as 
the commenter suggests.
    Paragraph (r)(3)(viii) of the certification program established by 
the April 2004 interim rule prohibited growing media and containers for 
articles of Pelargonium spp. and Solanum spp. from coming into contact 
with soil and prohibited the use of soil as a growing medium for 
articles of Pelargonium spp. and Solanum spp. One commenter 
hypothesized that pasteurized soil might in the future be considered an 
adequate growing medium and asked that, to ensure that the 
certification program could accommodate such a future development, we 
remove the prohibitions relating to soil and refer instead to APHIS-
approved growing media in paragraph (r)(3)(viii).
    We agree that it would be best to provide such flexibility in the 
regulations in the case that pasteurized soil becomes an acceptable 
growing medium. Therefore, we have changed paragraph (r)(3)(viii) of 
the certification program established by the April 2004 interim rule as 
the commenter requested. However, it is important to reiterate that 
soil of any kind will not be considered an APHIS-approved growing 
medium at this time.
    Paragraph (r)(3)(ix) of the certification program established by 
the April 2004 interim rule required that water used in maintenance of 
the plants at the production site be free of R. solanacearum R3B2. It 
also required that the production site derive the water from an APHIS-
approved source or treat the water with an APHIS-approved treatment 
before use. Two commenters expressed concerns about this requirement. 
One stated that no nurseries in the UK use surface water in the 
production of articles of Pelargonium spp., and infected Solanum 
dulcamara outside of contaminated watercourses have not been identified 
during official inspections over many years. Therefore, no water-borne 
route of transmission for R. solanacearum R3B2 into UK nurseries has 
been identified. The second commenter stated that rain water, tap 
water, or water from deep wells is used in the production of articles 
of Pelargonium spp. in the Netherlands, Belgium, and Germany.
    If the water sources cited by the commenters can be proven to be 
free of R. solanacearum R3B2, APHIS will approve the sources for use in 
the production of articles of Pelargonium spp. and Solanum spp. under 
the certification program; approval will be granted in the workplan 
developed among APHIS, the NPPO of the exporting country, and the owner 
or operator of the production site. We are making no changes to the 
April 2004 interim rule in response to these comments.
    Paragraph (r)(3)(x) of the certification program established by the 
April 2004 interim rule prohibited the use of ebb-and-flow irrigation 
in the production of articles of Pelargonium spp. and Solanum spp. 
under the certification program. We prohibited the use of ebb-and-flow 
irrigation because it exposes all the articles grown using such an 
irrigation system to any R. solanacearum R3B2 that may be present in 
any one article in the system. One commenter stated that ebb-and-flow 
irrigation should not be prohibited in production facilities located in 
areas within a country where R. solanacearum R3B2 is not known to 
occur.
    We agree that this requirement would be unjustified if an exporting 
country where R. solanacearum R3B2 is known to occur established, in 
accordance with the ``Requirements for the Establishment of Pest Free 
Areas'' referred to above, that an area within that country is free of 
R. solanacearum R3B2. In fact, under this final rule, production 
facilities in such a pest-free area would be eligible to export 
articles of Pelargonium spp. and Solanum spp. under paragraph Sec.  
319.37-5(r)(2)(ii) of the regulations, which requires only that the 
phytosanitary certificate accompanying the articles contain an 
additional declaration that states that the articles are from an area 
that has been established as free of R. solanacearum R3B2 in accordance 
with ISPM No. 4, ``Requirements for the Establishment of Pest Free 
Areas.'' However, as discussed above, APHIS has received no requests to 
establish such pest-free areas at this time.
    Paragraph (r)(3)(xii) of the certification program established by 
the April 2004 interim rule required that articles of Pelargonium spp. 
and Solanum spp. produced for export within an approved production site 
be handled and packed in a manner adequate to prevent the presence of 
R. solanacearum R3B2. One commenter recommended that the word 
``presence'' be changed to ``introduction,'' or that the word 
``introduction'' be added to this requirement.
    The intent of the certification program is to prevent the 
introduction of R. solanacearum R3B2 into the United States. Therefore, 
we agree with this commenter, and we have changed the word ``presence'' 
to ``introduction'' in paragraph (r)(3)(xii) of the certification 
program established by the April 2004 interim rule as the commenter 
suggests.
    Paragraph (r)(3)(xiii) of the certification program established by 
the April 2004 interim rule stated that if R. solanacearum R3B2 is 
found in the production site or in consignments from the production 
site, the production site will be ineligible to export articles of 
Pelargonium spp. or Solanum spp. to the United States. The paragraph 
further stated that a production site may be reinstated if a 
reinspection reveals that the production site is free of R. 
solanacearum R3B2 and all problems in the production site have been 
addressed and corrected to the satisfaction of APHIS.
    One commenter asked us to rewrite this paragraph to provide for the 
possibility of individual greenhouses in a production site to be 
declared ineligible to export articles of Pelargonium spp. or Solanum 
spp. to the United States if articles of Pelargonium spp. or Solanum 
spp. infected with R. solanacearum R3B2 can be traced back to an 
individual greenhouse in a production site, rather than declaring the 
entire production site ineligible.

[[Page 61359]]

    We believe it is safe to declare an individual greenhouse among 
several greenhouses ineligible to export articles of Pelargonium spp. 
or Solanum spp. to the United States only if the greenhouse is managed 
separately for phytosanitary purposes and thus qualifies as a 
production site itself, as specified in the definition of production 
site that the April 2004 interim rule added to Sec.  319.37-1. 
Otherwise, production practices in a production site composed of 
multiple greenhouses could spread R. solanacearum R3B2 from one 
greenhouse to another, meaning that it would not be safe to allow 
importation from any greenhouse in a production site in which one 
greenhouse produced articles of Pelargonium spp. or Solanum spp. 
infected with R. solanacearum R3B2. We are making no changes to the 
April 2004 interim rule in response to this comment.
    One commenter stated that production sites should have to be tested 
with negative results three times over a 90-day period in order to be 
considered eligible for reinstatement into the certification program. 
This commenter further requested that details of the testing that would 
be required for reinstatement and other requirements for reinstatement 
be included in the regulations.
    The three-test, 90-day standard the commenter suggests is a 
reasonable standard, but it may not be appropriate in all cases. We 
prefer to specify conditions for production site testing and 
reinstatement in the workplan developed among APHIS, the NPPO of the 
exporting country, and the operator of the production site, in order to 
take into account local production conditions and capabilities. We are 
making no changes to the April 2004 interim rule in response to this 
comment.
    Paragraph (r)(3)(xv) of the certification program established by 
the April 2004 interim rule required that the government of the country 
in which articles other than seed of Pelargonium spp. or Solanum spp. 
are produced enter into a trust fund agreement with APHIS before each 
growing season. The government of the country in which the articles are 
produced or its designated representative is required to pay in advance 
all estimated costs that APHIS expects to incur through its involvement 
in overseeing the execution of paragraph (r)(3) of this section. These 
costs will include administrative expenses incurred in conducting the 
services enumerated in paragraph (r)(3) of Sec.  319.37-5 and all 
salaries (including overtime and the Federal share of employee 
benefits), travel expenses (including per diem expenses), and other 
incidental expenses incurred by the inspectors in performing these 
services. The government of the country in which the articles are 
produced or its designated representative is required to deposit a 
certified or cashier's check with APHIS for the amount of the costs 
estimated by APHIS. If the deposit is not sufficient to meet all costs 
incurred by APHIS, the agreement further requires the government of the 
country in which the articles are produced or its designated 
representative to deposit with APHIS a certified or cashier's check for 
the amount of the remaining costs, as determined by APHIS, before the 
services will be completed. After a final audit at the conclusion of 
each shipping season, any overpayment of funds would be returned to the 
government of the country in which the articles are produced or its 
designated representative or held on account until needed.
    One commenter stated that the trust fund requirement adds an 
economic cost to the production of articles of Pelargonium spp. or 
Solanum spp. that does not contribute to the maintenance of plant 
health and is therefore not justifiable.
    The trust fund requirement is common practice under many other 
APHIS import regulations (e.g., importing Fuji apples from Japan and 
the Republic of Korea under Sec.  319.56-2cc, or importing Hass 
avocados from Mexico under Sec.  319.56-2ff). The trust fund is 
intended to ensure that the government of the country in which the 
articles are produced or its designated representative bears the cost 
of the certification program, rather than U.S. taxpayers. (The 
government of the country in which the articles are produced is, of 
course, free to pass this cost on to production sites producing 
articles of Pelargonium spp. or Solanum spp. for export to the United 
States.) Requiring that APHIS subsidize the production of articles of 
Pelargonium spp. or Solanum spp. grown in foreign countries for export 
to the United States would, we believe, be a misallocation of APHIS' 
limited resources. We are making no changes to the April 2004 interim 
rule in response to this comment.
    Two commenters expressed concern about the administration of the 
trust fund. One stated that there is no assurance that the governments 
of countries in which articles of Pelargonium spp. or Solanum spp. are 
produced will participate in setting up the trust fund; without such 
assurance, exporters might not be able to participate due to 
governmental reluctance. The other asked that APHIS itself, rather than 
the exporting country, establish and administer the trust fund so that 
it will cover the APHIS costs without making it uneconomical for 
exporting companies to continue production.
    APHIS does, in fact, establish and administer the trust fund in the 
certification program established in the April 2004 interim rule. The 
government of the country in which the articles are produced or its 
designated representative deposits money into the fund in response to 
APHIS estimates of costs and in response to actual costs as determined 
by APHIS. As noted above, the government of the country in which the 
articles are produced is free to pass this cost on to production sites 
producing articles of Pelargonium spp. or Solanum spp. for export to 
the United States. We are making no changes to the April 2004 interim 
rule in response to these comments.
    In the section of the April 2004 interim rule in which we responded 
to comments, we described one comment as suggesting that APHIS impose 
an import bond on all imports of articles of Pelargonium spp. or 
Solanum spp. Two commenters on the April 2004 interim rule stated that 
we should require an import bond; one suggested that an import bond 
would be appropriate if compensation is not provided for articles of 
Pelargonium spp. or Solanum spp. destroyed during eradication efforts.
    We continue to believe that the certification program we 
established in that interim rule is a more direct and more effective 
means of ensuring that articles of Pelargonium spp. and Solanum spp. 
that are offered for importation will not serve as a pathway for the 
introduction of R. solanacearum R3B2.

Other Comments

    One commenter recommended that, rather than place restrictions on 
the importation of articles of Pelargonium spp. or Solanum spp., we 
simply prohibit the importation of all nursery stock. We do not believe 
such an action is necessary or warranted.
    One commenter suggested that R. solanacearum R3B2 should be removed 
from the list of select agents in 7 CFR 331.3(a). We continue to 
believe, based on input from USDA's Agricultural Research Service, 
Forest Service, and Cooperative State Research, Education, and 
Extension Service and consultation with the American Phytopathological 
Society, that R. solanacearum R3B2 poses a severe threat to plant 
health or plant products, and the commenter

[[Page 61360]]

provided no evidence to the contrary. In any case, removing R. 
solanacearum R3B2 from that list is beyond the scope of this 
rulemaking.
    One commenter urged APHIS to continue with its review of the 
nursery stock regulations, to prevent introductions of both R. 
solanacearum R3B2 and other plant pests. We agree that this review is 
essential to safeguarding plant health, and we published an advance 
notice of proposed rulemaking soliciting comments on approaches to 
revising the nursery stock regulations on December 10, 2004 (69 FR 
71736-71744, Docket No. 03-069-1).
    Three commenters addressed various aspects of the eradication 
effort that APHIS undertook after the presence of R. solanacearum R3B2 
was confirmed in the United States in February 2003, including 
reinstatement procedures for facilities where R. solanacearum R3B2 was 
present, the speed with which the eradication effort was conducted, the 
treatment of individual greenhouses as production sites, and the fact 
that APHIS did not pay compensation to the owners of plants destroyed 
during this eradication effort.
    The effort to eradicate R. solanacearum R3B2 within the United 
States was conducted under the authority granted to APHIS in the Plant 
Protection Act (7 U.S.C. 7714), which states that if the Secretary 
considers it necessary in order to prevent the dissemination of a plant 
pest or noxious weed that is new to or not known to be widely prevalent 
or distributed within and throughout the United States, the Secretary 
may hold, seize, quarantine, treat, apply other remedial measures to, 
destroy, or otherwise dispose of any plant that is moving into or 
through the United States or interstate, or has moved into or through 
the United States or interstate, and the Secretary has reason to 
believe is infested with a plant pest or noxious weed at the time of 
the movement. The Plant Protection Act further states that if that 
situation should occur, the Secretary may order the owner of any plant 
to destroy the plant without cost to the Federal Government and in the 
manner the Secretary considers appropriate.
    The May 2003 and April 2004 interim rules placed restrictions on 
the importation of articles of Pelargonium spp. or Solanum spp. in 
order to address the risk that such importation could introduce R. 
solanacearum R3B2 into the United States; the domestic eradication 
effort is beyond the scope of this rulemaking.
    Therefore, for the reasons given in the interim rule and in this 
document, we are adopting the interim rule as a final rule, with the 
changes discussed in this document.
    This final rule also affirms the information contained in the 
interim rule concerning Executive Orders 12372 and 12988 and the 
Paperwork Reduction Act.

Effective Date

    Pursuant to the administrative procedure provisions in 5 U.S.C. 
553, we find good cause for making this rule effective less than 30 
days after publication in the Federal Register. The interim rule 
adopted as final by this rule was effective on May 24, 2004. This rule 
clarifies certain requirements in the certification program established 
by the interim rule and amends other requirements to provide additional 
options. Immediate action is necessary to amend the certification 
program in order to ensure that its requirements are easily understood 
and to make the certification program more flexible. Therefore, the 
Administrator of the Animal and Plant Health Inspection Service has 
determined that this rule should be effective upon publication in the 
Federal Register.

Executive Order 12866 and Regulatory Flexibility Act

    This rule has been reviewed under Executive Order 12866. The rule 
has been determined to be not significant for the purposes of Executive 
Order 12866 and, therefore, has not been reviewed by the Office of 
Management and Budget.
    In the April 2004 interim rule, APHIS amended the regulations to 
establish a certification program for articles of Pelargonium spp. and 
Solanum spp. imported from countries where the bacterium R. 
solanacearum R3B2 is known to occur. The interim rule prohibited the 
importation of articles of Pelargonium spp. and Solanum spp. from 
countries where R. solanacearum R3B2 is known to occur unless the 
articles are produced in accordance with the certification program. 
This final rule amends the regulations by modifying some of the 
requirements of the certification program to make them clearer and more 
flexible, by providing for the establishment of areas that are free of 
R. solanacearum R3B2 within countries where R. solanacearum R3B2 is 
known to occur, and exempting imported seeds of Pelargonium spp. and 
Solanum spp. from all requirements related to R. solanacearum R3B2. The 
requirements of the certification program are designed to ensure that 
R. solanacearum R3B2 will not be introduced into the United States 
through the importation of articles of Pelargonium spp. and Solanum 
spp. This certification program is necessary to prevent the 
introduction of this bacterial strain into the United States.
    The production site certification program impacts approximately 11 
different nurseries. Two of these nurseries are located in Guatemala, 
three in Mexico, one in China, two in Kenya, and three in Costa Rica. 
The average cost of upgrading these 11 production sites to comply with 
the production site requirements in the April 2004 interim rule has 
been estimated at approximately $70,000 per site.\10\ However, many of 
these production sites had already upgraded their facilities due to the 
outbreak of R. solanacearum R3B2 in early 2003. Thus, to the extent 
that these upgrades fulfill the production site requirements contained 
in this rule, compliance costs for some production sites would have 
been lower than this estimate.
---------------------------------------------------------------------------

    \10\ Society of American Florists.
---------------------------------------------------------------------------

Pelargonium (geranium) spp.

    Based on growers' receipts, U.S. floriculture and nursery crop 
sales totaled $14 billion in 2002. Total sales of U.S. geraniums were 
estimated at $204 million for 2002.\11\ The United States imported $44 
million worth of cuttings and slips of which geraniums comprised some 
unknown part.\12\ Geraniums are the most popular bedding plant in North 
America; approximately 20,000 growers cultivate these plants.
---------------------------------------------------------------------------

    \11\ Electronic Outlook Report from the Economic Research 
Service, Floriculture and Nursery Crops Outlook, September 12, 2002, 
Alberto Jerardo.
    \12\ World Trade Atlas 2002, U.S. imports of unrooted cuttings 
and slips of plants, code <greek-i> 0602100000.
---------------------------------------------------------------------------

    APHIS has determined that the 2003 R. solanacearum R3B2 outbreak 
occurred when geranium cuttings arrived from Kenya carrying the R. 
solanacearum R3B2 bacterium. The R. solanacearum R3B2 outbreak in 2003 
led to the disposal of 1.9 million geraniums; the disposed plants had a 
total value of approximately $1.5 to $2 million.

Solanum spp.

    The genus Solanum comprises a large group of both tender and hardy, 
herbaceous shrubby climbing plants. Several species can be found in 
North America either growing wild or as decorative plants, but two--
potatoes and eggplants--are grown as vegetables. The R. solanacearum 
R3B2 bacterium, which is widely distributed in temperate regions, 
causes the disease potato brown rot. In 2002, 1.3 million acres of U.S. 
potatoes were harvested;

[[Page 61361]]

the potato harvest was valued at $3.2 billion, and $123 million worth 
of U.S. potatoes were exported to the rest of the world.\13\ The value 
of potato fields infected with R. solanacearum R3B2 could be 
drastically reduced if not completely eliminated. The bacterium causes 
potatoes to have unsightly brown rings in the vegetable, making them 
worthless for human consumption. Most likely, U.S. producers with 
fields infected with this bacterium would be required to quarantine 
their fields and destroy the potatoes to prevent the spread of the 
disease.
---------------------------------------------------------------------------

    \13\ National Agricultural Statistical Service (NASS) data on 
U.S. potato production, 2002; Foreign Agricultural Service data on 
potato exports, 2002.
---------------------------------------------------------------------------

    The UK has experienced five outbreaks of potato brown rot that have 
caused minor impacts to overall potato production.\14\ Certain areas in 
South America have seen potato losses from 5 percent to 100 percent due 
to potato brown rot. If potato brown rot were to become established in 
the United States, the potato industry could potentially lose hundreds 
of millions of dollars due to direct losses and indirect losses from 
quarantines and diminished export markets.
---------------------------------------------------------------------------

    \14\ British Department of Environment, Food and Rural Affairs, 
Service Delivery Unit, Plant Health Division.
---------------------------------------------------------------------------

    The April 2004 interim rule allowed imports of articles of 
Pelargonium spp. and Solanum spp. to continue as long as the articles 
are produced in accordance with the certification program requirements 
in Sec.  319.37-5(r)(3) and are accompanied by a phytosanitary 
certificate stating that they have been produced in accordance with 
those requirements. The interim rule helped safeguard U.S. agriculture 
against the possible introduction of R. solanacearum R3B2.

Impact on Small Entities

    The Regulatory Flexibility Act requires that agencies consider the 
economic impact of their rules on small entities. The Small Business 
Administration (SBA) classifies nursery and tree production businesses 
as small entities (North American Industry Classification System 
category 111421) if their annual sales receipts are $750,000 or less. 
In 2001, 1,691 floriculture operations out of a total of 10,965 
operations had sales of $500,000 or more.\15\ Therefore, at least 85 
percent of all floriculture operations can be classified as small; it 
is likely that an even higher percentage can be classified as small due 
to the $250,000 discrepancy.
---------------------------------------------------------------------------

    \15\ NASS, Agricultural Statistics Board, U.S. Department of 
Agriculture, 2001 Floriculture Crops.
---------------------------------------------------------------------------

    The costs of complying with the production site certification 
requirements are not expected to significantly affect costs or revenues 
of small-entity floriculture operators in the United States. Some 
portion of the cost of site certification may be passed onto U.S. 
buyers of geranium cuttings in the form of higher prices, but this 
effect is expected to be minor.
    The interim rule had a negative impact on offshore operations due 
to the costs involved in complying with the additional nursery site 
certification requirements. Experts in the industry have estimated that 
updating the 11 offshore nursery sites cost approximately $770,000 
total, or $70,000 per site. However, this final rule makes changes to 
the production site requirements to allow affected entities some 
flexibility in meeting them. It is difficult to determine the impact 
without knowing average revenues generated at these 11 nursery sites.
    While the costs for production sites to comply with the 
requirements resulted in a negative impact on offshore production 
sites, the requirements help to ensure that future nursery shipments 
entering the United States are free of R. solanacearum R3B2. The 2003 
R. solanacearum R3B2 outbreak alone cost the floriculture industry $1.5 
to $2 million in geranium plant losses. The R. solanacearum R3B2 
outbreak could have jeopardized not only the entire U.S. geranium 
industry, which is estimated to be worth $204 million per year, but 
also the potato industry, which is estimated to be worth $3.2 billion 
per year, if it had not been contained and eradicated.\16\ It is 
evident that the benefits of certifying offshore production sites that 
produce Pelargonium spp. and Solanum spp. outweigh the costs.
---------------------------------------------------------------------------

    \16\ Electronic Outlook Report from the Economic Service, 
Floriculture and Nursery Crops Outlook, September 12th, 2002, 
Alberto Jerardo; and NASS data U.S. potato production, 2002, along 
with FAS data on potato exports 2002.
---------------------------------------------------------------------------

    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.

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, the interim rule amending 7 CFR part 319 that was 
published at 69 FR 21941-21947 on April 23, 2004, is adopted as a final 
rule with the following changes:

PART 319--FOREIGN QUARANTINE NOTICES

0
1. The authority citation for part 319 is revised 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. Section 319.37-5 is amended as follows:
0
a. By revising paragraph (r), introductory text, to read as set forth 
below.
0
b. By revising paragraph (r)(2) to read as set forth below.
0
c. In paragraph (r)(3), in the introductory text, by adding the words 
``or area'' after the word ``country.''
0
d. By revising the second sentence of paragraph (r)(3)(iii) to read as 
set forth below.
0
e. By revising paragraphs (r)(3)(iv) and (r)(3)(v) to read as set forth 
below.
0
f. In paragraph (r)(3)(vii), by removing the words ``must not come in 
contact with soil, and soil may not be used as a growing medium'' and 
adding the words ``must not come in contact with growing media that 
could transmit R. solanacearum race 3 biovar 2 and must be grown in an 
APHIS-approved growing medium'' in their place.
0
g. In paragraph (r)(3)(xii), by removing the word ``presence'' and 
adding the word ``introduction'' in its place.


Sec.  319.37-5  Special foreign inspection and certification 
requirements.

* * * * *
    (r) Any restricted article of Pelargonium spp. or Solanum spp. 
presented for importation into the United States may not be imported 
unless it meets the requirements of this paragraph (r). Seeds are not 
subject to the requirements of this paragraph (r).
    (1) * * *
    (2) (i) For any article of Pelargonium spp. or Solanum spp. that 
does not meet the requirements of paragraph (r)(1) of this section and 
is from a country where Ralstonia solanacearum race 3 biovar 2 is not 
known to occur, the phytosanitary certificate of inspection required by 
Sec.  319.37-4 must contain an additional declaration that states 
``Ralstonia solanacearum race 3 biovar 2 is not known to occur in the 
country or area of origin''; Provided, that this additional declaration 
is not required on the phytosanitary certificate of inspection 
accompanying articles of Solanum spp. from Canada that do not meet the

[[Page 61362]]

requirements of paragraph (r)(1) of this section.
    (ii) For any article of Pelargonium spp. or Solanum spp. that does 
not meet the requirements of paragraph (r)(1) of this section and is 
from an area that has been established as free of Ralstonia 
solanacearum race 3 biovar 2 in accordance with International Standards 
for Phytosanitary Measures Publication No. 4, ``Requirements for the 
Establishment of Pest Free Areas,'' which is incorporated by reference 
at Sec.  300.5 of this chapter, the phytosanitary certificate required 
by Sec.  319.37-4 must contain an additional declaration that states 
``This article is from an area that has been established as free of 
Ralstonia solanacearum race 3 biovar 2.''
    (3) * * *
    (iii) * * * Only articles of Pelargonium spp. and Solanum spp. from 
a group of articles that has been tested according to an APHIS-approved 
testing protocol with negative results for the presence of R. 
solanacearum race 3 biovar 2 may be used in production and export. * * 
*
    (iv) Each greenhouse on the production site must be constructed in 
a manner that ensures that runoff water from areas surrounding the 
greenhouses cannot enter the greenhouses. The greenhouses must be 
surrounded by a 1-meter buffer that is sloped so that water drains away 
from the greenhouses.
    (v) Dicotyledonous weeds must be controlled both within each 
greenhouse on the production site and around it. The greenhouses on the 
production site and the 1-meter buffer surrounding them must be free of 
dicotyledonous weeds.
* * * * *

    Done in Washington, DC, this 18th day of October 2005.
Elizabeth E. Gaston,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 05-21168 Filed 10-21-05; 8:45 am]
BILLING CODE 3410-34-P